For approximately 6 months
Leads, manages, and coordinates C&Q execution associated to Facilities, Utilities and Equipment (FEU). Develops overall documentation and execution plan for FEU. The resource must also prepare summary reports and/or presentations to communicate status, issues, and timing to customers, inspectors and management. Generates engineering documentation associated to the C&Q process, such as maintenance plans, spare parts lists, as-built drawings, among other. Generates and executes Change Requests (CRs) associated to engineering changes. Accountable for investigations, CAPAs and other compliance documentation associated to FEU C&Q activities. The resource will work with internal and external customers.
1. Leads the Commissioning and Qualification (C&Q) program for the site while providing support but not limited to Annual Product Reviews, Investigations, Audits and other systems supported by the program.
2. Keep abreast of latest industry practices and reviews C&Q documentation for cGMP compliance with current regulatory requirements (FDA, ISPE, WHO, etc.), trade journals, formal training and Quality expectations.
3. Participate in the identification, selection and provide guidance to contracted resources as needed to accomplish project objectives.
4. Evaluate, execute and/or coordinate FEU related C&Q activities to meet deliverables within budget and on schedule.
5. Participate in project team meetings, update schedules, and maintain communication within the internal team, contractors and the client, as required for C&Q related tasks.
6. Monitors and influence the performance of the C&Q executions by using metrics, reports, assessments, recommendations, etc.
7. Liaising with contractors, technical, quality and/or production staff.
8. Knowledge of industry practices and current Good Manufacturing Procedures (cGMP’s) requirements in facilities and processing; knowledge of FDA and international regulatory guidelines.
9. Knowledge of the general operation of pharmaceutical manufacturing, packaging and testing equipment and processes.
10. Knowledge of the general components and operations of regulated Facilities, Utilities and Equipment systems as they relate to C&Q activities.
11. Maintains strong internal and external relationships.
12. Participate in Computer System Validation (CSV) documentation and execution, as necessary.
13. Comply with all environmental trainings, procedures, guidelines, practices, cGMP’s, permit conditions and internal notifications of any environmental event.
14. Perform any other job-related duties as required or that may arise in the future.
EDUCATION AND EXPERIENCE
• Bachelor’s degree in Science or Engineering
• Minimum of five (5) years of experience in a highly regulated industry like Pharmaceuticals and/or Medical Devices.
• A minimum of three (3) years of C&Q or related experience.
• Experience managing engineering aspects of C&Q preferred (generation of maintenance plans, generation of spare parts lists, etc.