PSC Biotech® Corporation
Join to apply for the
CQV 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.
The Experience With operations spanning the globe and featuring a multicultural team, PSC Biotech® is passionate about bringing the best and brightest together. When you join our team, you can explore your professional passions and work alongside a group of people who value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. You will be offered a competitive compensation and benefits structure that rewards you, and you will be provided with the tools to grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role CQV Engineers are responsible for supporting commissioning, qualification, and validation projects for pharmaceutical facilities, utilities, equipment, and systems. You will play a key role in executing CQV deliverables and ensuring operational readiness from the ground up to support our clients’ success.
Assist in commissioning and startup of new equipment, utilities, and cleanroom systems during facility buildout.
Develop and execute IQ/OQ/PQ protocols for newly installed systems and equipment.
Prepare and maintain documentation, including validation protocols, plans, reports, and SOPs.
Support risk assessments and mitigation strategies related to CQV activities.
Troubleshoot and assist in resolving issues related to equipment and process performance.
Collaborate with cross-functional teams to align CQV activities with construction and project timelines.
Coordinate with vendors and contractors to support hand-offs and system turnover.
Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
Provide technical support during validation execution and qualification activities.
Additional responsibilities as required.
Requirements
Bachelor’s degree in engineering or a related field.
5+ years of commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
Proven experience supporting or leading CQV activities during new facility buildouts, including equipment installation and startup.
Strong background in cleanroom facilities, process equipment, and utility systems.
Familiarity with project execution and project management tools.
Deep understanding of regulatory requirements and industry standards (GMP, GAMP, FDA, EMA).
Knowledge of validation lifecycle and risk-based approaches.
Excellent analytical and technical problem-solving skills.
Strong technical writing skills and experience with validation documentation (protocols, reports, procedures, etc.).
Effective communication and interpersonal skills.
Organized, proactive, and detail-oriented with a commitment to quality and compliance.
Travel is required. Many of our projects and clients are located in various regions; we value candidates who are willing and able to travel as needed for project assignments and client engagements.
We offer a full suite of benefits: medical, dental, vision (PSC pays 100% of qualifying employee premiums and 50% for qualifying dependents); employee assistance programs; basic life insurance; short/long term disability; 401(k) and matching; PTO, sick time, and paid holidays; education assistance; pet insurance; Anytime Fitness discounted rate; financial perks and discounts.
Salary Adhering to California's law on salary transparency, the salary bracket for this role is set between $90,000 – $120,000 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
Engineering and Information Technology
Referrals increase your chances of interviewing at PSC Biotech® Corporation by 2x.
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CQV 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.
The Experience With operations spanning the globe and featuring a multicultural team, PSC Biotech® is passionate about bringing the best and brightest together. When you join our team, you can explore your professional passions and work alongside a group of people who value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. You will be offered a competitive compensation and benefits structure that rewards you, and you will be provided with the tools to grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role CQV Engineers are responsible for supporting commissioning, qualification, and validation projects for pharmaceutical facilities, utilities, equipment, and systems. You will play a key role in executing CQV deliverables and ensuring operational readiness from the ground up to support our clients’ success.
Assist in commissioning and startup of new equipment, utilities, and cleanroom systems during facility buildout.
Develop and execute IQ/OQ/PQ protocols for newly installed systems and equipment.
Prepare and maintain documentation, including validation protocols, plans, reports, and SOPs.
Support risk assessments and mitigation strategies related to CQV activities.
Troubleshoot and assist in resolving issues related to equipment and process performance.
Collaborate with cross-functional teams to align CQV activities with construction and project timelines.
Coordinate with vendors and contractors to support hand-offs and system turnover.
Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
Provide technical support during validation execution and qualification activities.
Additional responsibilities as required.
Requirements
Bachelor’s degree in engineering or a related field.
5+ years of commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
Proven experience supporting or leading CQV activities during new facility buildouts, including equipment installation and startup.
Strong background in cleanroom facilities, process equipment, and utility systems.
Familiarity with project execution and project management tools.
Deep understanding of regulatory requirements and industry standards (GMP, GAMP, FDA, EMA).
Knowledge of validation lifecycle and risk-based approaches.
Excellent analytical and technical problem-solving skills.
Strong technical writing skills and experience with validation documentation (protocols, reports, procedures, etc.).
Effective communication and interpersonal skills.
Organized, proactive, and detail-oriented with a commitment to quality and compliance.
Travel is required. Many of our projects and clients are located in various regions; we value candidates who are willing and able to travel as needed for project assignments and client engagements.
We offer a full suite of benefits: medical, dental, vision (PSC pays 100% of qualifying employee premiums and 50% for qualifying dependents); employee assistance programs; basic life insurance; short/long term disability; 401(k) and matching; PTO, sick time, and paid holidays; education assistance; pet insurance; Anytime Fitness discounted rate; financial perks and discounts.
Salary Adhering to California's law on salary transparency, the salary bracket for this role is set between $90,000 – $120,000 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
Engineering and Information Technology
Referrals increase your chances of interviewing at PSC Biotech® Corporation by 2x.
#J-18808-Ljbffr