Biotech Validation Specialist
2 weeks ago
PSC Biotech Corporation is a leading biotechnology consultancy firm with a global presence. Our mission is to provide innovative solutions for quality management and regulatory inspections in the pharmaceutical industry.
As a Senior CQ/Validation Engineer, you will play a key role in supporting the transition of our facilities from construction to commercialization. You will be responsible for validating equipment and processes to ensure compliance with regulatory requirements and industry standards.
Key Responsibilities:
- Equipment Qualification: Validate equipment and systems to ensure they meet regulatory requirements and industry standards.
- Process Validation: Validate manufacturing processes to ensure they are controlled and consistent.
- Cleaning and Particulate Matter (CPM) Control: Develop and implement effective cleaning and CPM control strategies to prevent contamination.
- Ancillary Equipment Qualification: Qualify ancillary equipment such as tube sealers, welders, and filter integrity testers.
Requirements:
- Minimum 6 years of experience in a similar role.
- Strong knowledge of current Good Manufacturing Practices (cGMP) and regulatory requirements.
- Experience with process validation, equipment qualification, and cleaning and CPM control.
- Ability to work independently and collaboratively as part of a team.
Preferred Qualifications:
- Experience with DeltaV and associated new phase development and qualification works.
- Project Management experience or training in use of Project Management tools and software tools.
- Knowledge of ASTM E2500, Eudralex, FDA, and ISPE guidelines.
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