Bachem Holding AG
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The Senior/Principal CSV Engineer supports GMP operations by leading validation activities for computerized systems used in API and PMO manufacturing. This includes equipment, facilities, and utilities. The role involves collaborating with cross-functional teams to plan, execute, and document CSV efforts, monitor validated systems, conduct periodic reviews, and manage related investigations.
What you will do Ensure compliance of all relevant computer systems and applications with applicable regulatory requirements, including 21 CFR Part 11 and EU GMP Annex 11, by performing Computer System Assessments and validation activities for Category 3, 4, and 5 systems. Develop, review, and maintain comprehensive validation lifecycle documentation such as risk assessments, validation plans, standard operating procedures (SOPs), test protocols, summary reports, and periodic reviews to ensure ongoing system compliance. Collaborate closely with local and central Quality Assurance (QA) teams to align on validation strategies, resolve compliance issues, and support audit readiness. Actively participate in site-level projects, managing all aspects of computer system validation and qualification, including planning, execution, deviation handling, and documentation. Serve as the CSV representative during regulatory inspections and partner audits, providing subject matter expertise and preparing detailed responses to CSV-related inquiries from auditors and inspectors.
Qualifications Bachelors degree computer science. engineering or science discipline. Minimum of 5 years of hands-on experience in computer system validation, and in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports. Extensive experience validating complex GxP computer systems, including CAT 3–5 systems, in compliance with 21 CFR Part 11 and EU GMP Annex 11. Skilled in developing and executing validation documentation: risk assessments, validation plans, DQ, SDS, IOQ/PQ, traceability matrices, SOPs, and reports. Manage system changes and upgrades through formal change control processes. Conduct Computer System Periodic Reviews and maintain validated state throughout the system lifecycle. Collaborate with QA, IT, and cross-functional teams to ensure systems meet regulatory and business requirements. Represent CSV during regulatory inspections and audits, providing expert responses. Strong communication, organization, and problem-solving skills; able to work independently or in teams. Proficient in Microsoft Office tools and experienced in cGMP environments, including lab and manufacturing systems. Oversee contractor/vendor activities and support hands-on system implementation and troubleshooting
Base Annual Salary Range: Principal CSVEngineer: $ 125,539 - 172,616 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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What you will do Ensure compliance of all relevant computer systems and applications with applicable regulatory requirements, including 21 CFR Part 11 and EU GMP Annex 11, by performing Computer System Assessments and validation activities for Category 3, 4, and 5 systems. Develop, review, and maintain comprehensive validation lifecycle documentation such as risk assessments, validation plans, standard operating procedures (SOPs), test protocols, summary reports, and periodic reviews to ensure ongoing system compliance. Collaborate closely with local and central Quality Assurance (QA) teams to align on validation strategies, resolve compliance issues, and support audit readiness. Actively participate in site-level projects, managing all aspects of computer system validation and qualification, including planning, execution, deviation handling, and documentation. Serve as the CSV representative during regulatory inspections and partner audits, providing subject matter expertise and preparing detailed responses to CSV-related inquiries from auditors and inspectors.
Qualifications Bachelors degree computer science. engineering or science discipline. Minimum of 5 years of hands-on experience in computer system validation, and in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports. Extensive experience validating complex GxP computer systems, including CAT 3–5 systems, in compliance with 21 CFR Part 11 and EU GMP Annex 11. Skilled in developing and executing validation documentation: risk assessments, validation plans, DQ, SDS, IOQ/PQ, traceability matrices, SOPs, and reports. Manage system changes and upgrades through formal change control processes. Conduct Computer System Periodic Reviews and maintain validated state throughout the system lifecycle. Collaborate with QA, IT, and cross-functional teams to ensure systems meet regulatory and business requirements. Represent CSV during regulatory inspections and audits, providing expert responses. Strong communication, organization, and problem-solving skills; able to work independently or in teams. Proficient in Microsoft Office tools and experienced in cGMP environments, including lab and manufacturing systems. Oversee contractor/vendor activities and support hands-on system implementation and troubleshooting
Base Annual Salary Range: Principal CSVEngineer: $ 125,539 - 172,616 Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Platinum Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.
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