Be an early applicantLess than 25 applicantsPosted by Agency
Synectics Inc. ยท 2 days ago
Equipment Validation Engineer
Summit, NJ
Contract
Onsite
Mid, Senior Level
5+ years exp
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Insider Connection @Synectics Inc.
Responsibilities
Supports the successful implementation of various process/lab equipment at multi-use sites through interaction with internal customers and external service providers.
Tasks include 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.
Uses basic analytical skills to recognize and solve common problems of limited scope.
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.
Supervises vendors for qualification functions.
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.
Interfaces with customers to ensure all expectations are being met.
Maintains a positive relationship with all team members and site customers while promoting a positive team environment.
Ensures equipment, facilities, and programs are maintained in compliance.
Qualification
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Required
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
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
Must Have: Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls
Preferred
Experience in the qualification of cell therapy equipment a plus
Highly preferred cell therapy equipment commissioning qualification
Benefits
Healthcare Insurance
Dental Insurance
Vision Insurance
401(k) Plan
Technical Certification Bonus
Company
Synectics Inc.
Synectics is one of the nation's foremost IT consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Melissa Lounds
Executive Vice President, Strategic Partnerships
Recent News
2024-06-04
MarketScreener
2024-06-04
2024-04-24
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