This position is responsible for Equipment and Sterilization Validation processes (i.e. included but not limited to Autoclave, SIP, tunnel, dry heat, and VHP studies), that supports commercial and new R&D drug development activities in support of the client projects involving all delivery systems manufactured in Lakewood, NJ plant.

This highly technical and highly specialized position is responsible for generating, reviewing and approving protocols, deviations and reports; as well as scheduling activities, providing internal and external customer feedback, and ensuring on-time delivery of milestone activities. The individual will be a Subject Matter Expert (SME) expected to oversee and execute the overall qualification activities related to the support activities or prerequisites to Process Performance Qualifications (PPQs, otherwise known as Process Validation).

This position will also interact frequently with regulatory/compliance personnel at Renaissance Lakewood LLC. It will ensure compliance to all FDA and international regulations with regard to equipment qualification and sterilization validation activities. The employee in this role must be able to represent Renaissance with customers and senior management.

1. Provide technical expertise and understanding on the qualification, requalification and requalification approach surrounding equipment, sterilization, and sanitization processes.
2. Prepare validation protocols and reports for the initial and requalification of process equipment, critical utility systems, and environmental chambers.
3. Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, VMPs, APRs, etc.
4. Perform validation activities within an aseptic pharmaceutical environment.
5. Implementation of applicable regulatory requirements and guidance ensuring compliance with FDA, ISO, EMA and any other applicable domestic and international regulation.
6. Provide technical support for all start-up activities related to temperature mapping, and sterilization programs.
7. Support periodic requalification activities for production equipment and systems.
8. Lead or provide technical support for root cause investigations related to sterilization, and other related activities.
9. Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
10. Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of sterilization processes.
11. Participate or provide guidance for equipment sterilization programs during internal and external audits, including regulatory inspections, as needed.
12. Provide technical assistance for investigations into process/product issues in support of the validation deviations and review of design requirements for products and or equipment.
13. Interface with customers on transfer discussions, timelines, project deliverables, etc.
14. Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Bachelors or masters degree in Pharmaceutical Sciences, Engineering, Microbiology or similar degree and a minimum of three (3) years of relevant experience performing validation activities within an aseptic pharmaceutical environment is required.
Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH. Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.