Equipment Validation Engineer
3 weeks ago
Yoh is looking for an Equipment Validation Engineer to come in and join our pharmaceutical client.
Industry: Pharmaceutical
Location: Summit, NJ (on site)
Compensation: $70-$78/hr (cannot accept C2C for this opportunity)
Type: 6 Month Contract
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.
Responsibilities
- Commissioning and qualifying new equipment facilities, utilities and maintaining equipment systems in a qualified / validated state according to established policies and procedures
- 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 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.
Education and Experience
- 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
- Highly preferred cell therapy equipment commissioning qualification.
Knowledge, Skills, and Abilities
- 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.
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