-
Sr. Validation Engineer
1 week ago
Katalyst Healthcares and Life Sciences Lakewood, United StatesResponsibilities: Responsible for the validation studies required for qualifying Manufacturing, Packaging equipment and Pharmaceutical facility and utilities, including: Classified areas, HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean ...
-
Sr. Validation Engineer, Equipment
2 days ago
Renaissance LLC Lakewood Township, United StatesRenaissance LLC · All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legal ...
-
Sr. Validation Engineer, Equipment
1 week ago
Renaissance LLC San Francisco, United States PermanentRenaissance LLC · All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legal ...
-
Sr. Validation Engineer, Equipment
1 week ago
Renaissance Lakewood, LLC Lakewood, United StatesOverview: · 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 ...
-
Sr. Validation Engineer
2 weeks ago
Katalyst HealthCares & Life Sciences Lakewood, United StatesResponsibilities: Provide technical expertise and understanding of the qualification, prequalification, and requalification approach surrounding equipment, sterilization, and sanitization processes. · Prepare validation protocols and reports for the initial requalification of p ...
-
Validation Engineer
1 day ago
Piper Companies Trenton, United StatesPiper Health and Sciences is actively seeking a Senior Validation Engineer to join a large global biotechnology company in the greater Trenton NJ area. · Responsibilities for Senior Validation Engineer: · Commissioning, qualification, and validation of biopharmaceutical manufac ...
-
Validation Engineer
1 week ago
Kelith Group Inc San Francisco, United States PermanentKelith Group Inc has openings for the positions of Validation Engineer with master's degree in Mechanical/Manufacture Engineering, Management, or related and 1 year of exp in executing Engineering test plans (ETP) for new and modified systems/equipment. Develop protocols for vali ...
-
Validation Engineer
3 weeks ago
Acara Solutions, An Aleron Company Trenton, United StatesAcara Solutions is seeking a Validation Engineer for its successful client who are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals. Our products and services stand for reliability ...
-
Validation Engineer
1 week ago
Sun Pharmaceutical Industries New Brunswick, United StatesJob Title: Validation Engineer - Pharmaceutical · Job Summary: · The Validation Engineer is responsible for completing assigned job of equipment validation, packaging validation, computers validation, utility equipment validation, commissioning support to meet cGMP requirements ...
-
Sr. Validation Engineer(CSV)
1 week ago
Katalyst Healthcares and Life Sciences Princeton, United StatesResponsibilities : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. · Should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP ...
-
Computer System Validation Engineer
3 weeks ago
TK-CHAIN LLC Princeton, United StatesJob Description · Job DescriptionResponsibilities · Lead the design, development, implementation, and execution of test scripts/test plans to identify software problems and their causes. · Coordinate and execute performance and functional testing associated with multiple concurre ...
-
Facility Validation Engineer
4 weeks ago
Kaztronix New Brunswick, United StatesFacilities Validation Engineer · No C2C or sponsorship · The Validation Engineer is responsible for completing assigned equipment validation, packaging validation, computers validation, cleaning validation, and process areas to meet cGMP requirements. · Job Function: · Prepare ...
-
Senior Automation Controls Engineer
12 hours ago
RBW Consulting Lakewood, United StatesMy client, a growing organisation in the pharmaceutical and biotech space are recruiting an experienced Senior Automation Controls Engineer who will be responsible for the installation, upkeep, and resolution of issues pertaining to automation systems for the automated utility, p ...
-
Project Manager/Engineer
2 days ago
Remington & Vernick Engineers Lakewood, United StatesPOSITION SUMMARY:If you're looking for rewarding work with the opportunity to grow, read on to learn how you can bring your expertise to a firm that combines state of the art technology with a history of success. This challenging position is structured to offer the successful can ...
-
Lead Fleet Technician
2 weeks ago
BlueTriton Brands Careers Lakewood Township, United States Permanent, Full timeBlueTriton is a leading provider of spring and purified water products - the name behind your favorite bottled water brands. We are proud to offer an extensive portfolio of highly recognizable, responsibly sourced, and sustainably packaged spring water in addition to other qualit ...
-
Senior Automation Controls Engineer
1 week ago
Rbw Consulting Lakewood, United StatesMy client, a growing organisation in the pharmaceutical and biotech space are recruiting an experienced Senior Automation Controls Engineer who will be responsible for the installation, upkeep, and resolution of issues pertaining to automation systems for the automated utility, p ...
-
Process Engineer II
1 week ago
Renaissance Lakewood, LLC Lakewood, United StatesOverview: · Responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production process by applying systems engineering principles and technology of chemistry, ...
-
Sr. Process Engineer
1 week ago
Renaissance Lakewood, LLC Lakewood, United StatesOverview: · Responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production process by applying systems engineering principles and technology of chemistry, ...
-
Process Engineer II
1 week ago
Renaissance LLC San Francisco, United States PermanentRenaissance LLC · All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legal ...
-
Process Engineer II
1 week ago
Renaissance LLC Lakewood, United StatesJob Description · Job DescriptionRenaissance LLC · All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, ge ...
Senior Validation Engineer - Lakewood, United States - MRINetwork Jobs
Description
Job Description
Job DescriptionJob Title: Sr. Validation Engineer, Equipment & Sterilization
Location: US-NJ
Overview:
This position is responsible for Equipment and Sterilization Validation processes (i.e. including 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. It will ensure compliance to all FDA and international regulations concerning equipment qualification and sterilization validation activities. The employee in this role must be able to represent Renaissance with customers and senior management.
Responsibilities:
1. Provide technical expertise and understanding of the qualification, prequalification, and requalification approach surrounding equipment, sterilization, and sanitization processes.
2. Prepare validation protocols and reports for the initial requalification of process equipment, critical utility systems, and environmental chambers.
3. Prepare, review, approve, and provide technical support for the 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 regulations.
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.
Qualifications:
Bachelors or master's 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.