-
Sr. Validation Engineer, Equipment
4 days 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 ...
-
Sr. Validation Engineer, Equipment
2 weeks ago
Renaissance Services Lakewood, 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 lega ...
-
Sr. Validation Engineer, Equipment
1 week ago
Renaissance LLC Lakewood, 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 Services Lakewood, 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
4 days 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 i ...
-
Sr. Validation Engineer, Equipment
2 weeks 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 i ...
-
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, Equipment
5 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 ...
-
GQR Lakewood, United StatesTitle: Sr. Validation Enginee Equipment and Sterilization · Location: Lakewood, NJ · Status: Full-time direct hire, onsite · Experience: Minimum of 5 years experience with validation · Compensation: $115,000 · This role is not set up for C2C and cannot offer any Visa sponsorship ...
-
GQR Lakewood, United StatesTitle: Sr. Validation Enginee Equipment and Sterilization · Location: Lakewood, NJ · Status: Full-time direct hire, onsite · Experience: Minimum of 5 years experience with validation · Compensation: $115,000 · This role is not set up for C2C and cannot offer any Visa sponsor ...
-
Equipment Engineer
3 days ago
System One Trenton, United StatesJob Title : Equipment Engineer · Location : Warren, NJ · Hours/Schedule : Monday - Friday; 1st Shift · Type: · Contract · Job Description · The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites throu ...
-
Equipment Engineer
5 days ago
Eclaro Trenton, United StatesPURPOSE AND SCOPE OF POSITION: · The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers. The incumbe ...
-
Equipment Engineer
1 week ago
Primary Talent Partners, Inc. Trenton, United States3 days ago · Be among the first 25 applicants · Primary Talent Partners has an opening as an Equipment Engineer with one of our global Pharmaceutical clients. This is an initial 12-month contract to start. · 100% onsite · Contract: 12- month to start · Target Pay: $57-61/hour ...
-
Equipment Engineer
1 week ago
Axelon Trenton, United StatesJob Description: 100% onsite · PURPOSE AND SCOPE OF POSITION:The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external s ...
-
Equipment Engineer
1 week ago
Yoh, A Day & Zimmermann Company Trenton, United StatesJob Description · Job Description Yoh is hiring an LSM Equipment Engineer to join our client working towards buliding a sustainable pipeline of potential therapies, leveraging translational medicine and data analytics to achieve the best outcome. The LSM Equipment Engineer will ...
-
Equipment Engineer
4 days ago
Sunrise Systems Trenton, United States100% onsite · PURPOSE AND SCOPE OF POSITION: · The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service provid ...
-
Equipment Engineer
5 days ago
Aequor Inc Trenton, United StatesPosition: Equipment Engineer · Location: · Warren NJ 07059 · Duration: 12 months (possibility of extension for the right candidate depending on performance) · Pay rate: $61.08/ hour on W2 · 100% onsite · EDUCATION AND EXPERIENCE · BS in Engineering or Science related discipli ...
-
Equipment Engineer
1 week ago
Knewin Trenton, United StatesJob Description: 100% onsite · PURPOSE AND SCOPE OF POSITION: · The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and externa ...
-
Equipment Engineer
5 days ago
Pyramid Consulting Trenton, United StatesImmediate need for a talented · Equipment Engineer . This is a · 12+ Months · contract opportunity with long-term potential and is located in · Warren, NJ (Onsite). · Please review the job description below and contact me ASAP if you are interested. · Job ID: · Pay Range: ...
-
Engineering - Equipment Engineer
1 week ago
TechDigital Corporation Trenton, United States100% onsite · 1. PURPOSE AND SCOPE OF POSITION: · The LSM(Lab Systems Management) Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, ...
Sr. Validation Engineer, Equipment - Lakewood, United States - Renaissance Services
Description
Renaissance 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 legally protected status.
US-NJ-Lakewood
Job ID:
Type:
Regular Full-Time
# of Openings:
1
Category:
MS&T
Lakewood, NJ
Overview
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.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.
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.
Compensation details:
Yearly Salary
PI4954e
About the Company:
Renaissance LLC
#J-18808-Ljbffr
