100 % Onsite Position

BS in Engineering or Science related discipline required.

PURPOSE and SCOPE of this POSITION:

• The Equipment Validation Engineer supports the successful implementation of laboratory and manufacturing equipment and utilities 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 workgroup to achieve team goals while building trust and collaborative relationships outside the immediate organization.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Understanding of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
• Knowledge of pharmaceutical, manufacturing and laboratory systems qualification preferred.
• 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 an extensive background in database systems.
• Innate ability to learn new software, such as corporate intranet and enterprise business.

EDUCATION and EXPERIENCE:

• BS in Engineering or Science related discipline required.

DUTIES AND RESPONSIBILITIES:

• Maintains qualified equipment systems in compliance with policies, guidelines and procedure
• Manages projects of limited scope and complexity within their functional area
• Provides excellent customer service and support

Job Type: Contract

Salary: $46.48 - $54.00 per hour

Schedule:

• 8 hour shift
• Day shift

Ability to commute/relocate:

• Summit, NJ 07901: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• equipment validation: 3 years (Preferred)
• Understanding of cGMP, GXP, GAMP, SDLC regulations: 3 years (Preferred)
• 21CFR part 11: 3 years (Preferred)
• computer systems validation requirements: 3 years (Preferred)
• pharma or medical device industry: 3 years (Preferred)
• equipment qualification: 3 years (Preferred)

Work Location: One location

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