PSC Biotech
San Diego, United States | Posted on 12/08/2025
PSCBiotech provides the life sciences with essential services toensure that health care products are developed, manufactured,and distributed to the highest standards, in compliance withall applicable regulatory requirements.
Our goalis to skyrocket our clients’ success, and you can be a partof our team’s achievements. Employing a global team ofskilled professionals and experts that span acrossstrategically located offices in North America, Europe, Asiaand the Middle East, we are proud of the roles we havefulfilled to help our clients achieve success.
The Experience Withoperations spanning the globe and featuring a multi-culturalteam, PSC Biotech® is passionate about bringing the best andbrightest together in an effort to form something trulyspecial. When you make the decision to join our team, youwill be offered the ability to feel inspired in your career,explore your professional passions, and work alongside agroup of people who will value and nurture your talents.
We arefirm believers in coaching and developing the next generationof industry leaders and influencers. As such, you will notonly be offered compensation and benefits structure thatrewards you, but also be provided with the tools that willhelp you grow and learn.
At PSCBiotech®, it’s about more than just a job—it’s about yourcareer and your future.
Your Role We are hiring an experienced Validation Engineerto support equipment, process, software, and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably, safely, and in compliance with cGMP, Annex 11, and global regulatory standards. This role involves planning, writing, implementing, and executing validation protocols to ensure consistent product quality and regulatory compliance.
Perform execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems.
Generate and execute validation documentation for manufacturing equipment, utilities, and computerized systems in accordance with cGMP, GxP, and Annex 11 requirements.
Support CQV activities for sterile injectable manufacturing equipment and site utilities, ensuring seamless integration and qualification.
Lead CSV efforts, including risk assessments, validation plans, and test scripts for computerized systems to maintain data integrity.
Validate and qualify various equipment and utilities i.e Depyrogenation Ovens
Troubleshoot and resolve issues related to validated equipment, processes, and systems; implement CAPA as needed.
Maintain accurate validation documentation and ensure audit readiness.
Additional responsibilities as assigned to drive project success.
Requirements
Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences.
4–5 years of validation experience within pharmaceutical, biotech, or medical device industries.
Strong knowledge of CSV and CQV principles, including regulatory expectations for sterile injectable manufacturing.
Familiarity with Annex 11, data integrity requirements, and industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations.
Experience with equipment, cleanroom systems, HVAC, purified water, compressed air, and other critical utilities.
Proficiency in writing and executing IQ/OQ/PQ protocols, validation reports, and computerized system validation documentation.
Strong analytical and problem-solving skills.
Excellent written and verbal communication abilities.
Strong time management and organizational skills.
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 include 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 $90,000 to $125,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement PSC iscommitted to is committed to a policy of Equal EmploymentOpportunity with respect to all employees, interns, andapplicants for employment. Consistent with this commitment,our policy is to comply with all applicable federal, stateand local laws concerning employment discrimination.Accordingly, the Company prohibits discrimination againstqualified employees, interns and applicants in all aspects ofemployment 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 activitiesand programs, including wellness, social and recreationalprograms. Employment decisions will be made without regard to anapplicant’s, employee’s, or intern’s actual or perceived: race,color, religion, sex (including pregnancy, gender identity, andsexual orientation), national origin, age (40 or older),disability, genetic information, or any other status protected bylaw.
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PSCBiotech provides the life sciences with essential services toensure that health care products are developed, manufactured,and distributed to the highest standards, in compliance withall applicable regulatory requirements.
Our goalis to skyrocket our clients’ success, and you can be a partof our team’s achievements. Employing a global team ofskilled professionals and experts that span acrossstrategically located offices in North America, Europe, Asiaand the Middle East, we are proud of the roles we havefulfilled to help our clients achieve success.
The Experience Withoperations spanning the globe and featuring a multi-culturalteam, PSC Biotech® is passionate about bringing the best andbrightest together in an effort to form something trulyspecial. When you make the decision to join our team, youwill be offered the ability to feel inspired in your career,explore your professional passions, and work alongside agroup of people who will value and nurture your talents.
We arefirm believers in coaching and developing the next generationof industry leaders and influencers. As such, you will notonly be offered compensation and benefits structure thatrewards you, but also be provided with the tools that willhelp you grow and learn.
At PSCBiotech®, it’s about more than just a job—it’s about yourcareer and your future.
Your Role We are hiring an experienced Validation Engineerto support equipment, process, software, and facility validation activities in a regulated life sciences environment. The Validation Engineer will play a key role in ensuring that all systems and equipment operate reliably, safely, and in compliance with cGMP, Annex 11, and global regulatory standards. This role involves planning, writing, implementing, and executing validation protocols to ensure consistent product quality and regulatory compliance.
Perform execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems.
Generate and execute validation documentation for manufacturing equipment, utilities, and computerized systems in accordance with cGMP, GxP, and Annex 11 requirements.
Support CQV activities for sterile injectable manufacturing equipment and site utilities, ensuring seamless integration and qualification.
Lead CSV efforts, including risk assessments, validation plans, and test scripts for computerized systems to maintain data integrity.
Validate and qualify various equipment and utilities i.e Depyrogenation Ovens
Troubleshoot and resolve issues related to validated equipment, processes, and systems; implement CAPA as needed.
Maintain accurate validation documentation and ensure audit readiness.
Additional responsibilities as assigned to drive project success.
Requirements
Bachelor’s degree in Engineering (Mechanical, Chemical, or related field) or Life Sciences.
4–5 years of validation experience within pharmaceutical, biotech, or medical device industries.
Strong knowledge of CSV and CQV principles, including regulatory expectations for sterile injectable manufacturing.
Familiarity with Annex 11, data integrity requirements, and industry standards such as ASTM E2500, ISPE Baseline Guides, and cGMP regulations.
Experience with equipment, cleanroom systems, HVAC, purified water, compressed air, and other critical utilities.
Proficiency in writing and executing IQ/OQ/PQ protocols, validation reports, and computerized system validation documentation.
Strong analytical and problem-solving skills.
Excellent written and verbal communication abilities.
Strong time management and organizational skills.
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 include 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 $90,000 to $125,000 annually. The offered salary may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.
Equal Opportunity Employment Statement PSC iscommitted to is committed to a policy of Equal EmploymentOpportunity with respect to all employees, interns, andapplicants for employment. Consistent with this commitment,our policy is to comply with all applicable federal, stateand local laws concerning employment discrimination.Accordingly, the Company prohibits discrimination againstqualified employees, interns and applicants in all aspects ofemployment 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 activitiesand programs, including wellness, social and recreationalprograms. Employment decisions will be made without regard to anapplicant’s, employee’s, or intern’s actual or perceived: race,color, religion, sex (including pregnancy, gender identity, andsexual orientation), national origin, age (40 or older),disability, genetic information, or any other status protected bylaw.
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