Responsibilities:
- Provide direct services to site Technical Services management, contributing to increased throughput of commissioning and qualification activities across the site.
- Collaborate with Technical Services management while independently performing required validation activities.
- Support C&Q activities across the site as directed by site Technical Services management.
- Review commissioning and qualification documentation for accuracy, technical soundness, and compliance with site and regulatory guidelines.
- Contribute to projects, including new facilities/equipment startup, commissioning, FAT, manufacturing equipment qualification, laboratory equipment qualification, and computerized and automation systems.
- Assist in the development of user requirement and functional specifications.
- Generate and execute commissioning and qualification documentation, including demonstration batches, thermal studies, validation studies, software validation, and final reports.
- Recommend to management the acceptance and release of qualified systems.
- Actively participate during all phases of validation projects, providing technical information to others.
- Review technical and quality system documents, ensuring compliance with validation principles and regulatory requirements.
- Review various documentation and drawings to ensure changes meet quality and validation requirements and comply with regulations and standards.
- Provide technical assistance during investigations of process/equipment/cleaning/validation issues.
- Support, investigate, and troubleshoot problems, determining possible solutions.
- Provide effective solutions for the management of system deviations and non-conformances.
Job Requirements:
- Bachelor's degree in a technical field (engineering, biology, chemistry, pharmacy).
- 4 - 7 years of applied technical experience in the pharmaceutical or biotech industries.
- Hands-on commissioning, qualification, and validation experience in at least two of the following disciplines: Facilities (including design, flow analysis, HVAC), Utilities (including WFI / RO/ purified water, clean steam, clean air, compressed air and gases, process waste systems), major equipment, process/cleaning and equipment validation/qualification, or computer software validation.
- Firm understanding of cGMP validation requirements/guidelines and current industry practices.
For CQV Specialists in QA:
1 Person:
- Oversight of all CQV activities requires 1 experienced individual to oversee CSV, with 7 - 8 years of experience in CSV or QA oversight.
- CSV for writing validation PLANS ONLY, not protocols for different CSV.
- May keep 1 or 2 contractors to support process validation activities, reviewing protocols and reports after the contract is over.
2 Persons:
- 2 QA individuals providing oversight for C&Q activities, IOQP, etc., on manufacturing systems, facilities, utilities, process equipment (e.g., P&I review), and reviewing reports
2 Persons:
- Another 2 for QC oversight, overseeing AMV, C&Q activities of Lab systems, reviewing reports
