Job Description: This position is responsible for the successful implementation and coordination of equipment and facilities validation programs in compliance to cGMPs, FDA requirements and company policy. Development and execution of equipment and facilities validation protocols is the primary responsibility of this position. Inherent is the responsibility to ensure the accuracy and completeness of each validation study and that each study is acceptable to FDA standards and requirements.
Responsibilities:
- Participate in the commissioning, qualification and start-up of various pharmaceutical cGMP process and packaging equipment, utilities & facilities.
- Coordinate, develop and prepare installation, operation and performance qualification protocols for production equipment and production related facilities validation. Including the validation of manufacturing and packaging equipment, HVAC, Compressed Air and Purified Water systems.
- Coordinate and perform the execution of validation studies. Prepare validation reports, including data analysis, conclusions, and recommendations.
- Lead the development (for example, write test cases) of key qualification deliverables such as DQ, FAT, SAT, IQ, OQ and PQ during the project lifecycle.
- Able to perform field execution of qualification test cases and protocols.
- Lead qualification processes throughout the project lifecycle to ensure timely completion and to ensure all quality and engineering specifications are met.
- Possess knowledge of relevant regulatory requirements and industry best practices on all or any of the following - Process equipment, clean utilities, automation systems, laboratory equipment, building & facilities
- Perform other related assignments and duties as required and assigned.
Requirements:
- Bachelor's degree in engineering, a Scientific discipline, or a degree in some other discipline.
- 5+ years of experience in commissioning, qualification, validation of various systems within the pharmaceutical/biotech industry.
- Knowledge of cGMPs and FDA guidelines and regulations acquired through education, experience and training.
- Experience with commissioning & qualification of equipment & facilities is required.
- Validation experience such as cleaning validation, thermal validation, mixing studies, process validation, computer systems validation is an asset but not required.
- Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems are considered. an asset.
- Experience with preparation and execution of URS's, DQ's, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs
- Ability to handle multiple projects and work in a fast-paced environment.
- Strong multi-tasking skills.
- Effective written and oral communication skills.
- High proficiency in preparing documents with MS Word and editing Access Data Bases.
