- Offer technical expertise and insight on the qualification, requalification, and requalification approach for equipment, sterilization, and sanitization processes.
- Develop validation protocols and reports for initial and requalification of process equipment, critical utility systems, and environmental chambers.
- Prepare, review, approve, and offer technical support for the preparation of relevant technical documents, such as: change controls, deviation investigations, validation protocols and summary reports, processing records, procedures, VMPs, APRs, etc.
- Conduct validation activities within an aseptic pharmaceutical setting.
- Enforce applicable regulatory requirements and guidance to ensure compliance with FDA, ISO, EMA, and other applicable domestic and international regulations.
- Provide technical support for all start-up activities related to temperature mapping and sterilization programs.
- Support periodic requalification activities for production equipment and systems.
- Lead or provide technical support for root cause investigations related to sterilization, among other related activities.
- Analyze manufacturing data using statistical principles for identifying trends, process disruptions, and areas for continuous improvement.
- Collaborate with cross-functional process teams to implement projects aimed at enhancing productivity, quality, or continual improvement of sterilization procedures.
- Participate in or provide guidance for equipment sterilization programs during internal and external audits, including regulatory inspections, if necessary.
- Offer technical assistance for investigations into process/product issues to support validation deviations and review design requirements for products and equipment.
- Communicate with customers regarding transfer discussions, timelines, project deliverables, etc.
- Promote a safe work environment by adhering to safety regulations and cultivating a safety-oriented culture through active participation in safety-related activities.
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Sr. Validation Engineer, Equipment - Lakewood Township, United States - Renaissance LLC
Description
Renaissance LLC
All qualified candidates will be considered for this job opportunity, regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other protected status.
Sr. Validation Engineer, Equipment & Sterilization
Location: US-NJ-Lakewood
Job ID:
Type: Regular Full-Time
# of Openings: 1
Category: MS&T
Lakewood, NJ
Overview
This role is in charge of Equipment and Sterilization Validation processes (such as Autoclave, SIP, tunnel, dry heat, and VHP studies), which are essential for commercial and R&D drug development activities supporting client projects involving all delivery systems manufactured in Lakewood, NJ plant.
This position involves generating, reviewing, and approving protocols, deviations, and reports, scheduling activities, providing feedback to customers, both internal and external, and ensuring timely completion of milestone activities. The individual is a Subject Matter Expert (SME) responsible for overseeing and carrying out the qualification activities related to support activities or prerequisites for Process Performance Qualifications (PPQs, also known as Process Validation).
In addition, this role involves frequent interaction with regulatory/compliance personnel at Renaissance Lakewood LLC. It entails ensuring compliance with all FDA and international regulations regarding equipment qualification and sterilization validation activities. The employee in this position must represent Renaissance with customers and senior management.
Responsibilities
Qualifications
Bachelor's or master's degree in Pharmaceutical Sciences, Engineering, Microbiology, or related field, and a minimum of three (3) years of relevant experience performing validation activities in an aseptic pharmaceutical environment is required.
Familiarity with current industry practices and guidelines, including those mandated by the FDA, ISO, EU, and ICH. Proficiency in Microsoft Office tools like Word, Excel, PowerPoint, MS Project, Visio, etc.
Compensation Details: Yearly Salary
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