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Renaissance Lakewood, LLC · 2 days ago
Sr. Validation Engineer, Equipment & Sterilization
Lakewood, NJ
Full-time
Onsite
Mid Level
3+ years exp
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Responsibilities
Provide technical expertise and understanding on the qualification, requalification and requalification approach surrounding equipment, sterilization, and sanitization processes.
Prepare validation protocols and reports for the initial and requalification of process equipment, critical utility systems, and environmental chambers.
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.
Perform validation activities within an aseptic pharmaceutical environment.
Implementation of applicable regulatory requirements and guidance ensuring compliance with FDA, ISO, EMA and any other applicable domestic and international regulation.
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, and other related activities.
Analyze manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
Coordinate with cross-functional process teams for the implementation of projects identified to improve productivity, quality, or continuous improvement of sterilization processes.
Participate or provide guidance for equipment sterilization programs during internal and external audits, including regulatory inspections, as needed.
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.
Interface with customers on transfer discussions, timelines, project deliverables, etc.
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Qualification
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Required
Bachelors or master’s degree in Pharmaceutical Sciences, Engineering, Microbiology or similar degree
Minimum of three (3) years of relevant experience performing validation activities within an aseptic pharmaceutical environment
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.
Company
Renaissance Lakewood, LLC
Renaissance is a US-based contract development and manufacturing organization (CDMO) for pharmaceutical and biotech companies.
201-500 employees
H1B Sponsorship
Renaissance Lakewood, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2022 (3)
2021 (4)
2020 (2)
Funding
Current Stage
Growth StageLeadership Team
Robert Harrer
Vice President and CFO
Alexis Savoth
Human Resources Business Partner
Company data provided by crunchbase
