What are the responsibilities and job description for the CSV Engineer position at PSC Biotech® Corporation?
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are seeking an experienced Computer System Validation (CSV) Engineer to support Manufacturing Execution Systems (MES) within a GMP-regulated biopharmaceutical manufacturing environment. This role will focus on lifecycle validation activities, electronic batch record (EBR) systems, and ongoing compliance support for commercial manufacturing operations. The ideal candidate has strong MES validation experience in biologics manufacturing and a solid understanding of GAMP 5, 21 CFR Part 11, and data integrity requirements.
W2 Temp positions offer our Medical and sick time benefits.
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $95,000 - $110,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are seeking an experienced Computer System Validation (CSV) Engineer to support Manufacturing Execution Systems (MES) within a GMP-regulated biopharmaceutical manufacturing environment. This role will focus on lifecycle validation activities, electronic batch record (EBR) systems, and ongoing compliance support for commercial manufacturing operations. The ideal candidate has strong MES validation experience in biologics manufacturing and a solid understanding of GAMP 5, 21 CFR Part 11, and data integrity requirements.
- Collaborate with project stakeholders and cross functional team to define project requirements.
- Perform execution of CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and User Acceptance Testing (UAT) for MES platforms.
- Generate and execute validation documents and ensure compliance with required GxP and 21 CFR Part 11 regulations.
- Participate in the planning, development, and implementation of computer systems validation documentation.
- Manage and validate protocols, electronic records, and electronic signatures ensuring data integrity and compliance. Support data and system transfers as needed.
- Ensure seamless integration of equipment as required.
- Initiate and oversee system CSV associated change control requests and associated validation documentation.
- Author, review, and approve scheduled periodic reviews.
- Troubleshoot and resolve issues related to validated systems, working closely with internal teams to implement corrective actions.
- Additional responsibilities as assigned to drive project success.
- Bachelor's degree in Engineering, Computer Science, or a related field.
- 5-7 years of computerized system validation experience within the life sciences/pharmaceutical industries.
- Strong working knowledge of backend systems, servers, databases, and system infrastructure as they relate to validated environments.
- Strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, Annex 11, etc.
- Hands-on validation experience with MES platforms.
- Proficiency in data integrity testing and compliance with FDA 21 CFR Part 11 regulations.
- Experience with equipment and system integration.
- Strong analytical skills with the ability to think critically and solve problems effectively.
- Excellent written and verbal communication skills.
- Strong time management and organizational abilities.
- Detail-oriented mindset with a commitment to maintaining high-quality standards.
- Must be authorized to work in the US.
- No C2C at this time.
W2 Temp positions offer our Medical and sick time benefits.
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $95,000 - $110,000 annually. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement
PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
Salary : $95,000 - $110,000