Key Responsibilities
- Commission, qualify, and validate facilities, utilities, and equipment in accordance with project and regulatory requirements.
- Support the development, review, and execution of CQV documentation, including protocols, reports, and validation deliverables.
- Assists to review and qualify equipment for commissioning, qualification, and validation activities.
- Assist with equipment qualification activities and ensure systems meet design and operational requirements.
- Participate in risk assessments, design reviews, FAT, SAT, IQ, OQ, PQ, and PV activities.
- Collaborate with clients, contractors, vendors, and cross-functional teams to successfully deliver project objectives.
Requirements
Requirements
- Bachelor's Degree in Engineering, Life Sciences, or a related discipline.
- 2+ years of experience in commissioning, qualification, and validation within pharmaceutical, biotech, or regulated environments.
- Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation.
- Experience developing SOPs, validation reports, and quality documentation.
- Good understanding of cGMP requirements and 21 CFR compliance.
- Previous experience with clean utility systems, particularly Purified Water (PW) and Water for Injection (WFI) systems.
- Experience commissioning, pressure testing, flushing, passivating, and qualifying pharmaceutical water systems.
- Knowledge of water system validation, sanitization, and lifecycle management activities.
- Strong communication, problem-solving, and stakeholder management skills.
Skills Required
- Bachelor's degree in Engineering, Life Sciences, or a related discipline
- 2+ years of commissioning, qualification, and validation experience within pharmaceutical, biotech, or regulated environments
- Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation
- Experience developing SOPs, validation reports, and quality documentation
- Understanding of cGMP requirements and 21 CFR compliance
- Experience with clean utility systems, particularly Purified Water and Water for Injection systems
- Experience commissioning, pressure testing, flushing, passivating, and qualifying pharmaceutical water systems
- Knowledge of water system validation, sanitization, and lifecycle management activities
- Strong communication, problem-solving, and stakeholder management skills
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
