Scope of Function:
The Senior Commissioning & Qualification Engineer is responsible for the generation of the validation master plan, initiates controlled documentation, executes facilities and equipment qualification, as well as creation and execution of protocols and writing/routing/obtaining approval of final reports. The position is expected to work cooperatively across all functions to support facility operations and launch of development products. This position requires extensive interaction with internal customers to identify qualification needs.
This individual shall have 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 qualification 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.
- Responsible for on time execution of Master Qualification Plan
- Initiates investigations, resolves technical issues and implements Corrective and Preventive Actions.
- Schedules and executes equipment requalification per Standard Operating Procedures (SOPs).
- Coordinates and communicates all testing with affected functional groups and evaluates test results.
- Develops User Requirement Specifications, Commissioning, 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).
- Performs risk assessments for new and existing equipment and facilities
- Conducts protocol deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventive actions (CA/PA).
- Identify key vendors to procure equipment, on-board the equipment, validate equipment and work through the Change Management process.
- Engineering (ME/EE/IE) or relevant biological science degree required along with 5 years of experience with GMP equipment onboarding/validation preferred.
- Project management or project execution experience in the pharmaceutical or related industry are required.
- Validation experience valued.
- Experience writing and executing validation protocols, requirement specifications and SOPs.
- Clear understanding of related SOPs and cGMPs as necessary to accomplish tasks.
- Understands basic machine functionality (e.g. PLC’s, servo motors, controls, pneumatic function, power requirements, and safety guards).
- Understands utility requirements when specifying equipment.
- Background of setting up and executing preventative maintenance and calibration programs.
- Communicates clearly with internal and external stakeholders, both verbal and written.
- Coordinates the development of engineering and GMP documentation, procurement, engineering services, construction, C&Q, and tech transfer.
- Join a high growth and fast paced organization with a client focused culture.
- Interact with clients from across the globe on cutting edge biotherapies.
- Competitive Medical, Dental, Vision and 401K.