[Hiring] CQV Engineer @PSC Biotech

Role Description

We are hiring a CQV Engineer to support projects within the pharmaceutical, biotechnology, and medical device industries. This is a remote position responsible for supporting commissioning, qualification, and validation (CQV) activities to ensure systems, equipment, and facilities meet regulatory requirements and project objectives.

• Support the execution of multiple validation and CQV projects, ensuring successful delivery of commissioning, qualification, and validation activities.
• Support multiple workstreams projects while providing updates to stakeholders and clients.
• Support the development, execution, and review of validation protocols and documentation, including DQ, FAT, SAT, IQ, OQ, PQ, and PV.
• Assist in commissioning, qualification, and validation of facilities, utilities, equipment, and systems within regulated environments.
• Ensure projects align with regulatory requirements, cGMP standards, and industry’s best practices.
• Coordinate risk assessments, design reviews, and project planning activities.
• Collaborate with internal teams, contractors, and vendors to support project deliverables.
• Present project progress, risks, and outcomes to clients and internal leadership teams.
• Make effective decisions when managing competing priorities or project challenges.
• Ensure proper documentation, reporting, and compliance with GMP and GDP standards.
• Additional duties and responsibilities may be assigned from time to time.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Business, or a related field.
• 3–5 years of experience in validation, CQV, or project management within the pharmaceutical, biotechnology, or medical device industries.
• Experience coordinating and managing multiple workstream projects.
• Experience with commissioning, qualification, and validation activities including DQ, FAT, SAT, IQ, OQ, PQ, and PV.
• Strong knowledge of cGMP, regulatory requirements, and validation practices.
• Experience with project planning, risk management, and cost control.
• Strong technical aptitude with the ability to understand multiple systems and technologies.
• Excellent communication, presentation, and stakeholder management skills.
• Strong time management, organizational, and leadership skills.
• Ability and willingness to travel as required.

Benefits

• 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.
• 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.