PSC Biotech® Corporation
CQV Engineer / PSC Biotech® Corporation
Join us as a CQV Engineer responsible for the commissioning, qualification, and validation of facilities, utilities, and equipment in the pharmaceutical and biotech industries. This role supports validation planning, documentation, and execution while ensuring regulatory compliance.
Responsibilities
Develop and execute commissioning, qualification, and validation protocols for required systems and equipment (e.g., process skids, chromatography skids).
Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
Identify and assess risks associated with CQV activities and develop effective mitigation strategies.
Troubleshoot and resolve issues related to equipment and process performance.
Collaborate with cross‑functional teams to ensure alignment on CQV activities and project timelines.
Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
Perform additional responsibilities as required to drive successful validation project deliverables.
Requirements
Bachelor’s degree in Engineering, Life Sciences, or a related field.
6–10 years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
Strong knowledge of regulatory requirements and industry standards.
Experience with validation lifecycle management and risk‑based approaches.
Excellent analytical and technical problem‑solving skills.
Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.).
Effective communication and interpersonal skills.
Proactive with strong organization, time management, and project management abilities.
Excellent attention to detail with commitment to quality and compliance.
Willingness to travel as needed for project assignments and client engagements.
Must be authorized to work in the U.S.
No C2C at this time.
Benefits W2 temporary positions include medical and sick time benefits.
Salary: $100,000–$120,000 annually, adjustable based on qualifications, skills, and 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. PSC prohibits discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, interviewing, hiring, evaluation, compensation, promotion, and all other employment decisions. This policy complies with all applicable federal, state, and local laws concerning employment discrimination.
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 2×.
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Responsibilities
Develop and execute commissioning, qualification, and validation protocols for required systems and equipment (e.g., process skids, chromatography skids).
Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
Identify and assess risks associated with CQV activities and develop effective mitigation strategies.
Troubleshoot and resolve issues related to equipment and process performance.
Collaborate with cross‑functional teams to ensure alignment on CQV activities and project timelines.
Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
Perform additional responsibilities as required to drive successful validation project deliverables.
Requirements
Bachelor’s degree in Engineering, Life Sciences, or a related field.
6–10 years of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
Strong knowledge of regulatory requirements and industry standards.
Experience with validation lifecycle management and risk‑based approaches.
Excellent analytical and technical problem‑solving skills.
Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.).
Effective communication and interpersonal skills.
Proactive with strong organization, time management, and project management abilities.
Excellent attention to detail with commitment to quality and compliance.
Willingness to travel as needed for project assignments and client engagements.
Must be authorized to work in the U.S.
No C2C at this time.
Benefits W2 temporary positions include medical and sick time benefits.
Salary: $100,000–$120,000 annually, adjustable based on qualifications, skills, and 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. PSC prohibits discrimination against qualified employees, interns, and applicants in all aspects of employment, including recruitment, interviewing, hiring, evaluation, compensation, promotion, and all other employment decisions. This policy complies with all applicable federal, state, and local laws concerning employment discrimination.
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 2×.
#J-18808-Ljbffr