- Location: Summit, New Jersey
- Type: Contract
- Job #79372
- BS in Engineering or Science related discipline required.
- 5 years' experience performing/supporting activities in a GMP environment.
- 3 years' experience in equipment, facility or utility qualification.
- 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 multitasking 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.
- 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.
- 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, andpreventive 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 company standards.
- 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.
- Ensure equipment, facilities and programs are maintained in compliance.
- May be called upon as SME in both internal and regulatory audits.
- Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs.
- Ability to sit, stand, walk and move within workspace for extended periods.
- Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
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Validation Engineer - Summit, United States - TSR Consulting
Description
About TSR:TSR is a relationship-based, customer-focused IT and technical services staffing company.
For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.
Mission & Vision
We do not believe in building a vision around the company but building a company around our vision, which is simply;
Every employee's voice matters, their effort is appreciated, and their talent is rewarded.
We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.
Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.
Validation Engineer
Job Description
Job ID #: 79372
Work Location:
Summit, NJ - 100% Onsite
Summary:
The Equipment Validation Engineer supports the successful implementation of various process/labequipment 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 maintaining equipment systems in a qualified / validated state according to established policies and procedures. The individual participates in projects and ongoing work activities of low to moderate complexity. With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
Knowledge/Skills/Education:
Maintains qualified equipment systems in compliance with policies, guidelines and procedures:
