Validation Engineer
3 weeks ago
Location: Summit, NJ
Type: Contract
Responsibilities
- Maintains qualified equipment systems in compliance with policies, guidelines and procedures:
- Develops qualification protocols, and associated reports while adhering to a change management process.
- Supports the execution of equipment qualifications and validation protocols.
- Supervises vendors for qualification functions.
- Develops written procedures for calibration and preventive maintenance of equipment.
- Supports equipment qualification and validation activities.
- Develops validation/qualification deliverables such as Validation Plans, Requirements
- Specifications, Traceability Matrices, Summary Reports, Change Controls.
- Manages projects of limited scope and complexity within their functional area:
- Supports equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turn over to business area.
- Supports internal customer groups in the procurement, operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates.
- Completes all qualification and validation documentation with accuracy, completeness and compliance to Celgene standards.
- Provides excellent customer service and support:
- Regularly reviews, prioritizes and promptly responds to customer equipment qualification and support requests.
- Provides technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met.
- Provides technical support and guidance on equipment and computer systems qualification and validations issues.
- Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
- Regulatory Responsibilities
- Ensure equipment, facilities and programs are maintained in compliance.
- May be called upon as SME in both internal and regulatory audits.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Experience in the qualification of cell therapy equipment a plus
- Advanced knowledge of pharmaceutical, manufacturing and laboratory systems.
- Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry.
- Strong written and verbal communication skills.
- Excellent interpersonal skills with experience dealing with a diverse workforce.
- Strong multi?tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
- Highly proficient computer skills in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
- BS in Engineering or Science related discipline required
- Minimum of 5 years' experience performing/supporting activities in a GMP environment.
- Minimum of 3 years' experience in equipment, facility or utility qualification
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
#M3
-
Summit, United States Artech Full timeValidation Engineer Pharmaceutical Summit, NJ 100% onsite Duration: 6 months(High Possibility of extension for right candidate) Highly preferred cell therapy equipment commissioning qualification. Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports,...
-
Summit, United States Sunrise Systems Full timeJob Title: Validation Engineer Job ID:(phone number removed) Location: Summit, NJ, 07901 Duration: 06 Months contract on W2100% Onsite positionPURPOSE AND SCOPE OF POSITION:The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external...
-
Validation Engineer
3 days ago
Summit, United States LanceSoft Full timeTitle: Engineering - Validation Engineer Location: Summit NJ 07901 Duration: 6 months(High Possibility of extension for right candidate) Comments: 100% onsite Highly preferred cell therapy equipment commissioning qualification. Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability...
-
Validation Engineer
2 days ago
Summit, United States LanceSoft Full timeTitle: Engineering - Validation Engineer Location: Summit NJ 07901 Duration: 6 months(High Possibility of extension for right candidate) Comments: 100% onsite Highly preferred cell therapy equipment commissioning qualification. Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications,...
-
Validation Engineer
5 days ago
Summit, United States LanceSoft Full timeTitle: Engineering - Validation Engineer Location: Summit NJ 07901 Duration: 6 months(High Possibility of extension for right candidate) Comments: 100% onsite Highly preferred cell therapy equipment commissioning qualification. Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability...
-
Validation Engineer
4 days ago
Summit, United States LanceSoft Full timeTitle: Engineering - Validation Engineer Location: Summit NJ 07901 Duration: 6 months(High Possibility of extension for right candidate) Comments: 100% onsite Highly preferred cell therapy equipment commissioning qualification. Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability...
-
Validation Engineer
2 days ago
Summit, United States On-Board Companies Full timeOn-Board Services is hiring a Validation Engineer in Summit, NJ! For immediate consideration please send your resume to Subject Line: Position Title and State you are Located About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees. We offer...
-
Validation Engineer
5 days ago
summit, United States Joulé Full timeJob Title: Validation EngineerLocation: Summit, NJType: ContractResponsibilitiesMaintains qualified equipment systems in compliance with policies, guidelines and procedures:Develops qualification pro...
-
Validation Engineer
4 days ago
Summit, United States Cynet Systems Full timeJob Description: Pay Range: $79hr - $81hr Responsibilities: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment facilities,...
-
Validation Engineer
2 days ago
Summit, United States Mindlance Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment ...
-
Validation Engineer
5 days ago
Summit, United States Axelon Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment...
-
Validation Engineer
5 days ago
Summit, United States Mindlance Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment...
-
Engineering - Validation Engineer
3 days ago
Summit, United States Omni Inclusive Full time100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and...
-
Validation Engineer
2 days ago
Summit, United States Axelon Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment ...
-
Engineering - Validation Engineer
2 days ago
Summit, United States HonorVet Technologies Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment...
-
Engineering - Validation Engineer
5 days ago
Summit, United States HonorVet Technologies Full timeJob Description: 100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment...
-
Engineering - Validation Engineer
5 days ago
Summit, United States Omni Inclusive Full time100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities and...
-
Sr. Validation Engineer
2 weeks ago
Summit, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities. This role will be responsible for drafting, reviewing and approving qualification protocols/reports and any associated documentation in support of CQV activities for a new facility. The Role...
-
Engineering - Validation Engineer
2 days ago
Summit, United States TechDigital Corporation Full time100% Onsite position PURPOSE AND SCOPE OF POSITION: The Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers. The incumbent in this is tasked with commissioning and qualifying new equipment facilities, utilities...
-
Equipment Validation Engineer
3 weeks ago
Summit, United States Yoh, A Day & Zimmermann Company Full timeYoh is looking for an Equipment Validation Engineer to come in and join our pharmaceutical client.Industry: PharmaceuticalLocation: Summit, NJ (on site)Compensation: $70-$78/hr (cannot accept C2C for this opportunity) Type: 6 Month ContractThe Equipment Validation Engineer supports the successful implementation of various process/lab equipment at multi-use...
