Website Goodwin Biotechnology
Scope of Function: The Commissioning & Qualification Engineer is responsible for supporting facilities and equipment qualification. The position is expected to work cooperatively across all functions to support facility operations and launch of development products.
This position requires a strong understanding of GMP’s and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility. Primary responsibilities are to provide technical support to engineering operations in terms of equipment/system initial validation and equipment/system requalification. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must have a comprehensive understanding of cGMPs.
Reports to: Associate Director of Facilities
- Schedules and executes equipment requalification per Standard Operating Procedures (SOPs).
- Coordinates and communicates all testing with affected functional groups and evaluates test results.
- Creation and execution of protocols and writing/routing/obtaining approval of final reports.
- Develops User Requirement Specifications, Functional Requirement Specifications for new equipment or modification of current equipment, and Site Acceptance Tests (SAT) for equipment.
- Writes qualification protocols for new equipment and facilities including, Installation Qualification (IQ) and Operational Qualification (OQ).
- Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventive actions (CA/PA).
- Identifies key vendors to procure equipment, on-board the equipment, validate equipment and work through the Change Management process.
- Identifies and quantifies technical risks and recommends appropriate action, e.g. reports calculations and recommendations in terms concrete enough for management to make an informed decision.
- Coordinate the development of engineering and GMP documentation, procurement, engineering services, construction, C&Q and Tech Transfer.
Education, Experience and Skills Required:
Education: Bachelor’s Degree in Engineering (ME/EE/IE) or relevant biological science degree required along with 3 – 5 years of experience with GMP equipment onboarding/validation preferred.
Experience: Project management or project execution experience in the pharmaceutical or related industry are required, validation experience preferred.
Writing and executing validation protocols, requirement specifications and SOPs. Must be proficient in the operation of Microsoft Office applications. Experience using thermal mapping and validation equipment (i.e. KAYE Validator, Data Loggers). Knowledge of related industry standards (ISO14644, EU Annex, CFR Parts 210&211) and cGMPs to accomplish tasks. Clear communication skills both written and verbal with internal and external stakeholders.