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 hiring a CSV Engineer to support the validation and lifecycle management of computerized and analytical systems. This role ensures systems are validated and maintained in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5, etc.). Successful candidates will have hands-on validation experience with laboratory and manufacturing systems in the pharmaceutical/life sciences industry.
This is a W2-Temp 5-month position with potential for extension.
This is a W2 Temp position. W2 Temp positions include medical benefits and sick time benefits.
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $80,000 - $125,000 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 is committed to 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 hiring a CSV Engineer to support the validation and lifecycle management of computerized and analytical systems. This role ensures systems are validated and maintained in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5, etc.). Successful candidates will have hands-on validation experience with laboratory and manufacturing systems in the pharmaceutical/life sciences industry.
This is a W2-Temp 5-month position with potential for extension.
- Develop, review, and execute validation protocols and deliverables including IOPQ protocols, design specifications, functional requirements, and summary reports for computerized, automated, and analytical lab/manufacturing systems.
- Manage system implementation activities including configuration, backup/restore, and data integrity verification.
- Perform system verification testing and periodic reviews.
- Write, review, and approve required SOPs.
- Provide user training and on-going technical support.
- Participate in risk assessment, CAPA implementation, and change control processes.
- Always ensure adherence to regulatory requirements.
- Additional responsibilities as required to drive project success.
- Bachelor’s degree in engineering or related technical discipline
- 3-7 years of experience in computer systems validation within GMP-regulated environments, with strong knowledge of GxP system lifecycle.
- Well-versed in validating computerized and automated systems such as DeltaV, Empower, etc.
- Proven experience in validating analytical laboratory instruments and supporting software such as spectroscopy, osmometers, etc.
- Strong understanding of regulatory requirements 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles.
- Strong technical writing skills and knowledge of full lifecycle documentation.
- Excellent attention to detail and commitment to quality and compliance.
- Strong problem solving and analytical skills.
- Must be authorized to work in the US.
- No C2C at this time.
This is a W2 Temp position. W2 Temp positions include medical benefits and sick time benefits.
Adhering to the requirements of California's law on salary transparency, the salary bracket for this role is set between $80,000 - $125,000 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 is committed to 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 : $80,000 - $125,000
