Bachem

Bachem Vista, CA, USA
Aug 17, 2019
Full time
Your Responsibilities The Director EHS will play a key role in driving a culture of excellence in health and safety with Bachem. The successful EHS leader must have a proven record showing a strong focus on safety, health and industrial and occupational hygiene and the ability to develop, maintain, and improve effective programs to ensure compliance with all applicable laws, regulations and company standards. This position requires a strong Health and Safety skill set and will work closely with the leadership team and HSE team in Torrance and Vista to implement and integrate site Health, Safety and Environment (EHS). Your Tasks Provides consultation and information in regards to work safety, fire safety, environmental protection, health protection and industrial hygiene. Investigates and evaluates root causes for accidents, incidents, near misses and occupational injuries / illnesses and monitors them Promotes a learning culture within the business to reduce the EHS risks and ensure a safe and compliant work environments for associates Provides leadership and administration of the overall EHS program by developing an annual plan, achieving consensus on the plan and objectives with the leadership team, and monitors the progress of the plan against objectives Ensures appropriate risk assessments are conducted and corrective actions implemented to minimize or eliminate injuries and environmental impact that may cause harm to associates, contractors, visitors, property or company reputation Promotes proactive contact with the industrial standard ensuring current industrial standards are known and implemented on the site Develops, administers, and updates the EHS Management System including procedures, programs, and forms Monitors compliance with current contractual, legal and regulatory requirements; conformance to current EHS MS requirements, and EHS performance results using both proactive and reactive measures Ensures EHS recordkeeping and data integrity in order to provide the business with accurate reporting and metrics to support EHS initiatives Applies appropriate best practices to identify and facilitate improvements to business processes, facilities and equipment, and safe work practices, including capital projects and management of change Supports leadership in resolving and closing out corrective and preventive actions for continual improvement of EHS compliance and performance Facilitates learning events for significant events and injury cases Reinforces safety awareness in a manner that promotes cooperation and improves enthusiasm and morale Practices safe work habits and complies with all quality, safety, health and environmental policies, procedures, programs and regulations Ensure compliance with all current California regulatory bodies and standards (including OSHA, EPA, AQMD, etc.) and fosters a good relationship with them. Identify project risks and create measurements to mitigate/eliminate those risks Responsible for creating, controlling and approving documents (SOP's, FMEA's, MBPR's, Risk analysis, operating procedures, etc.) Continuously organizing and conducting health, safety, occupational hygiene and environmental trainings to all employees at Bachem Americas (BAM) Research environmental regulations and policies and institute changes to ensure compliance Periodically review concepts, processes and standard operating procedures in order to guarantee good quality and effectiveness of the respective process Participates in the due diligence process for new business acquisitions and helps with the design of new facilities or major revisions of existing facilities to ensure proper EHS considerations are in place Conducts Corporate directed environmental self-assessments for each location annually Provides emergency preparedness standards with departments and participates in any emergency response and recovery efforts as needed Schedule and lead project meetings, controlling the assigned tasks and project time lines, preparing and dispersing information After completion of a project, ensuring the compliance of all implemented changes and actions in all upcoming CAPEX projects, equipment changes, process changes and operating procedures Leads and implements the "Good Hygiene Practice/Industrial Hygiene" project in accordance with headquarter and project roadmap Acts as the primary liaison on Industrial Hygiene matters between the Sites, Corporate, Customers, Regulatory Agencies, the Legal Department, and other legal entities Your Profile Bachelor's degree required (preferably in environmental health and safety) Minimum of 5 years of experience in performing and leading projects in the EHS & IH field Knowledge of California OSHA, EPA and AQMD standards Knowledge of pharmaceutical industrial standards Strong project management skills Capable of creating standard operating procedures in an efficient and flexible way (Mastercontrol) Ability to train, influence and motivate Bachem employees Some travel required inclusive international for trainings in our headquarter in Switzerland Excels in written and verbal communication English Excels in organizational skills Independent working, self-organizing and proactive person, but at the same time a strong team player that can get along with everybody Proficient with computer programs like Word, Excel, Power point, Outlook, etc. Detail oriented with the ability to troubleshoot and resolve problems accurately Ability to organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Preferred: Continuous education in the field of safety, health, environmental and industrial hygiene Knowledge of Lean Six Sigma 5S Emergency Response Team (ERT) experience We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.
Bachem Vista, CA, USA
Aug 04, 2019
Full time
Your Responsibilities Develop and train employees on utilization of maintenance schedule for new equipment Write and assist in composition of instruction and operating procedures of new equipment Support projects for facility remodeling and expansion Perform activities associated with the design and qualifications of the new and existing equipment used in a manufacturing plant Write design qualifications for qualifying batch processing tanks, filter dryers, HPLCs, filtration system, Lyophilizers, cold rooms, ultra-low freezers, HVAC, compressed air, and purified water (experience with cleaning, and automation controls) Relies on experience and judgment to plan and accomplish goals Create new process and equipment drawings based on specifications and standards Update drawings to reflect changes to existing process Maintains drawing files (CAD, PDF, and hard copies) Oversee the design and construction of new plants Troubleshoot process equipment and ensuring that equipment works to its specifications and appropriate capacities Draft of new procedures, SOP's and protocols as well as training of staff for these expectations Work with other departments, contractors and vendors Perform process development studies for new and existing projects. Write summary reports to support the process development data Write standard operation procedures, standard test procedures, master batch records and other related GMP documents Your Profile Bachelor's Degree in Engineering Minimum of 5 years' relative work experience Knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles Familiar with pharmaceutical and medical device regulated environment Technical knowledge of processes, equipment and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.) Experience with Computerized Maintenance Management Systems (CMMS) Experience managing projects and providing technical assessments Exhibit detail oriented documentation skills, technical writing and SOPs May work with hazardous materials and chemicals Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues. Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Experience with Peptides General lab instrument ( GC, FTIR, NMR and KF) knowledge and operation experience We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.
Bachem Vista, CA, USA
Aug 04, 2019
Full time
Your Responsibilities The Program Manager fulfills a critical role for the Central Function Quality Systems group. This individual will be responsible for assisting with the development/ harmonization of Quality Systems at Bachem US sites and subsequent maintenance and oversight of these systems. This position will collaborate with QA and other team members at sites in the US and Europe to implement different modules of MasterControl, an electronic quality management system (or other electronic tracking tools). This position will also assist with preparing the US sites for regulatory inspections and conducting audits on behalf of Bachem America sites. The incumbent will assist with developing metrics and issuing reports to assess the health of Bachem US quality systems. Your Tasks Develop metrics for Quality Systems in support of management review and various quality reports Assist with creation of shared Quality Systems documents for Bachem Americas sites to achieve harmonization Assist with implementation of different modules of Master Control software at Bachem US As part of the Central Function Quality System team you may be required to assist with maintenance/oversight of some of the following Quality Systems: Quality Event Reporting Document Management System Change Control/Equipment Change Control Data integrity program Supplier Quality program Material Qualification Program Internal audit program External audit program Annual Product Review Your Profile Required: Bachelor's Degree in a science related field - Chemistry, Biology or equivalent Minimum of 5 to 8 years of experience in quality assurance Extensive experience in cGMP manufacturing, Quality Control, or Quality Assurance Experience in writing standard operating procedures, specifications and technical reports Experience conducting audits Experience with the Material Qualification process Experience in developing quality system metrics Technical writing experience Excellent written and oral communication skills Excellent computer skills, including Microsoft Word, Excel and PowerPoint and Access Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Ability to interact well with co-workers, customers, regulatory agency auditors and senior management Communicate effectively and ability to function well in a team environment Preferred: Master's Degree in Science related field Experience with Master Control or other electronic quality management system Lean or six-sigma Green and/or Black belt certification We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.
Bachem Torrance, CA, USA
Aug 03, 2019
Full time
Your Responsibilities The Technical Writer will prepare technical protocols and associated technical reports for all manufacturing stages including synthesis, cleavage, purification and lyophilization. The Technical Writer will also be responsible for writing technical procedures such as Standard Operating Procedures (SOP's), Master Batch Production Records (MBPR), and other documentation following cGMP guidelines. Your Tasks Write technical protocols and associated technical reports for all manufacturing stages including synthesis, cleavage, purification, and lyophilization Write technical procedures, such as Standard Operating Procedures (SOP's), Mater Batch Production Records, and other documents following cGMP guidelines Review and complete cGMP documentation following cGMP guidelines Ensure collaboration between the Production department and other supporting departments such as Operations, Materials Management, QA and QC Adhere to manufacturing schedules and timelines Propose technical improvements in documentation Participate in the development of the new paradigm for validation Perform experiments for the new process justification Participate in improving the quality of documentation in all peptide manufacturing stages following cGMP guidelines Participate in project meetings including the weekly Production and R&D meetings Your Profile BS Degree in Organic Chemistry or related field Minimum of 3 years' work experience as a chemist or scientist in a cGMP environment or 3 years' technical writing experience Proficient with various in-process analytical methods Experience with cGMP manufacturing and documentation standards May work with hazardous materials and chemicals Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Master's in Organic Chemistry or related field Experience with peptide manufacturing stages and various in-process analytical methods Experience with cGMP manufacturing and documentation standards We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.
Bachem Vista, CA, USA
Aug 03, 2019
Full time
Your Responsibilities The Facilities Metrology Technician, under close supervision, performs routine calibration duties such as: tests, calibrations, repairing electrical, mechanical, electro-mechanical, and electronic measuring, recording, and indicating instruments and equipment for conformance to established standards. This individual will also be responsible for all related projects and services related to the facilities equipment and their timely completion while adhering to standard practices. In addition, he/she will be responsible for routine visual and physical inspections. . Your Tasks Dis-assembles instruments and equipment and inspects components for defects Measures parts for conformity with specifications Aligns, repairs, replaces, and balances component parts and circuitry Reassembles and calibrates instruments and equipment Devises formulas to solve problems in measurements and calibrations Performs all in house calibrations and maintains appropriate documentation Ensures all calibration standards are properly calibrated and certified Executes engineering and calibration portions of equipment qualifications Monitors HVAC parameters and changes temperature/humidity charts weekly Schedules, calibrates and verifies calibration of instrumentation under the Metrology program Assists in specifying instruments and standards and in drafting new and revised SOPs Participates in training programs, which, result in the development of a successful working understanding of the material presented and to become proficient in assigned duties and tasks Complies with all Company policies and procedures, including safety rules and regulations Responsible for calibrations of test and measuring instrumentation throughout the facility Responsible for completing scheduled and unscheduled calibration needs per GMP guidelines Provide support in planning and execution of shutdowns of equipment Responsible for trouble shooting and providing corrective action directives Participate in calibration process and cycle designs; implement the necessary process change through engineering change control procedures Collaborate with the validation department regarding change control requalification and validation of change Collaborate with Quality Assurance in PR and SOP writing, and participate in review and corrective action related to mechanical or process deviation of equipment Train staff members to ensure knowledge and efficiency on troubleshooting and maintaining of equipment Routinely makes technical decisions affecting equipment/facilities and processes Identifies critical issues, investigates alternatives, makes recommendations, and develops and implements plan(s) for resolution Provides assistance and guidance within work team to resolve technical and non-technical issues Assures calibration and test standards are being maintained Adapt equipment, standards and procedures to follow proper requirements Stay abreast of metrology aspects by learning new instructions, procedures, and equipment operations Follow applicable safety standards and procedures Work in accordance with company guidelines and cGMP processes Keeps the team informed of projects status and information Complete paperwork required for equipment and maintenance data into the department's and calibration processes Your Profile High School diploma 1-2 years of directly related experience with instrumentation, electrical systems, and calibration preferably in a bio/pharmaceutical or other related industry Specific knowledge of electrical components, pneumatic, and control components Ability to maintain a high level of documentation and audit trail for calibrated systems such as PLCS, Building Management Systems and other Controls monitoring systems Knowledge of Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), ISO and other regulatory requirements Experience with the Principles and practices of metrology Principles of mathematical and statistical computations Experience with proper techniques of instrumentation repair Knowledge of techniques of calibration (temperature, pressure, dimensional, mass, humidity) Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel, Access and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Must be able to work a rotating on-call schedule (for weekends) Preferred: Certifications in Metrology Higher education We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.
Bachem Torrance, CA, USA
Aug 03, 2019
Full time
Your Responsibilities The Manager of IT Applications is an experienced SAP SCM Specialist (MM,WM,PP,QM) with leadership skills, who will be responsible for managing our local applications team and provide SAP and other application related support and expertise in the US. In this challenging position, you will reporting to the Director of Global IT Applications and be responsible for the support, maintenance as well as the enabling of the further development of Bachem's SAP S/4HANA environment and all related business applications. Your Tasks Local responsibility for the reliable operation and development of the US enterprise and business application landscape Lead and develop local applications team Support, troubleshoot and advise the Torrance and Vista SAP SCM users Ensure the maintenance of existing SAP module, related business applications and interface configurations by strictly following common standard operational procedures (Incident, Problem, Change Management) to keep our systems validated (CSV) and GMP compliant Work and coordinate with business partners and SAP key users to translate business needs into globally harmonized solution proposals by following industry best practices (SAP for Chemicals in a GMP regulated environment) Coordination and prioritization of the implementation of above mentioned solutions by strictly following common standard operational procedures (Change and Release management) Ensure proper documentation and testing of all application related business processes and system configurations Your Profile BS degree or equivalent in IT Minimum 8 years of experience as a SAP SCM module expert/consultant (MM, WM, PP, QM), as well as basic overall SAP system management Ability to comprehend business requirements and the associated system capabilities Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Preferred: Experience in the chemical/pharmaceutical industry We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.
Bachem Vista, CA, USA
Jul 25, 2019
Full time
Your Responsibilities The Lyophilizer Maintenance Engineer will be responsible for maintenance, troubleshooting, and corrective actions for all lyophilizer equipment in current operation at the site. This individual will be responsible for all projects and services related to the lyophilizers including the timely completion of repairs while adhering to standard operating practices. In addition, he/she will be responsible for routine visual and physical inspections. Your Tasks Responsible for maintenance and operational procedure for over six freeze dryers Responsible for maintenance and operational procedure for lyophilizer equipment Participate in engineering designs, specifications selections, change of parts and implement necessary changes through engineering change control procedures Participate in lyophilization process and cycle designs; implement the necessary process change through engineering change control procedures Collaborate with the validation department regarding change control requalification and validation of change Participate in customer and end-user meetings related to lyophilization as the subject matter expert Participate in writing, review and implementation of corrective actions related to lyophilizer mechanical or process deviation Use understanding and knowledge of PLC control engineering to participate in making necessary changes in process and mechanical control Collaborate with Quality Assurance in PR and SOP writing, and participate in review and corrective action related to mechanical or process deviation of equipment Complete paperwork required for equipment and maintenance data into the department's and calibration processes Your Profile Bachelor's Degree in Electrical, Mechanical or Industrial Engineering with at least 6 years related experience or AA Degree with 10 years related experience or High school degree with 15 years experience Direct related experience with electronica controls and refrigeration system knowledge, including low temperature cascading systems and two stages compressor. Specific knowledge of vacuum systems, hydraulic system and electrical circuit and control Electronic controls and refrigeration systems knowledge, including low temperature cascading systems and two stages compressor Understanding / knowledge of PLC control, preferably Allen Bradley and OM RON. Strong analytical math and problem solving skills Proficient in reading schematics and diagrams as well as other written materials High level of safety awareness Excellent written and oral communication skills Basic computer knowledge, including Microsoft Word, Excel and PowerPoint Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Detail oriented with the ability to troubleshoot and resolve equipment problems Ability to work independently and manage one's time Communicate effectively and ability to function well in a team environment Flexibility of working hours based on business needs, may include some nights and occasional weekends Preferred: Experience with -50◦ Celsius refrigeration We Offer You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are looking for a new challenge and want to join a motivated team in an internationally renowned company, you should seize this opportunity.