PSC Biotech® Corporation
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Validation Engineer
role 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, we are proud of the roles we have fulfilled to help our clients achieve success.
Your Role We are hiring an experienced Validation Engineer to 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.
Benefits 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 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.
Seniority level Mid‑Senior level
Employment Type Full-time
Job Function Quality Assurance
Referrals Referrals increase your chances of interviewing at PSC Biotech® Corporation by 2x.
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Validation Engineer
role 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, we are proud of the roles we have fulfilled to help our clients achieve success.
Your Role We are hiring an experienced Validation Engineer to 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.
Benefits 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 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.
Seniority level Mid‑Senior level
Employment Type Full-time
Job Function Quality Assurance
Referrals Referrals increase your chances of interviewing at PSC Biotech® Corporation by 2x.
#J-18808-Ljbffr