21 Equipment Validation Engineer Jobs in Summit, NJ
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Equipment Validation Engineer
$109k-129k (estimate)
Contractor | Wholesale
3 Weeks Ago
Synectics Inc. is Hiring an Equipment Validation Engineer Near Summit, NJ
Description
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
- 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 maintaining equipment systems in a qualified / validated state according to established policies and procedures.
- 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.
- eMaintains qualified equipment systems in compliance with policies, guidelines and procedures
- Develops qualification protocols, and associated reports while adhering to a change management process.
- Supports execution of equipment qualifications and validation protocols for manufacturing and laboratory equipment, utilities and facility
- Temperature mapping of Controlled Temperature Units using wired or wireless mapping systems (e.g. Kaye Validator, Kaye ValProbes, Ellabs, etc.)
- Supervises vendors for qualification functions.
- Develops validation/qualification deliverables such as IOQ Protocols, Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, and 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.
- 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.
- BS in Engineering or Science related discipline required
- 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.
- 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.
- Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements
- Specifications, Traceability Matrices, Summary Reports, Change Controls.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
Job Summary
JOB TYPE
Contractor
INDUSTRY
Wholesale
SALARY
$109k-129k (estimate)
POST DATE
06/07/2024
EXPIRATION DATE
07/25/2024
WEBSITE
synectics.net
HEADQUARTERS
LEBANON, OH
SIZE
25 - 50
FOUNDED
1993
CEO
HEIDI BALE
REVENUE
<$5M
INDUSTRY
Wholesale
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About Synectics Inc.
Environmental Synectics, Inc. (Synectics) is a HUBZone certified small business enterprise with more than 25 years of experience providing environmental services, information technology services and advisory & assistance services to federal government agencies as well as commercial and Fortune 500 companies. Since our founding in 1993, we have successfully executed work for the U.S. Air Force, Army and Navy at scores of installations nationwide. Synectics architected and implemented the environmental industrys most versatile cloud-based data management system with integrated Automated Data Rev...iew (ADR) capabilities. Our Environmental Data Management System (EDMS) requires only a secure internet connection to allow project teams around the globe access to datasets, report generation capabilities, and communication with colleagues. Synectics EDMS provides comprehensive functionality to all environmental projects and is backed by a team of professionals committed to leveraging innovative technologies to optimize processes, reduce costs and shorten schedules for the benefit of our clients.
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