We are looking for a Remediation Engineering Specialist in Millburn, NJ for a 12+ months contract position.

Job Description:

Position: Remediation Engineering Specialist

Location: Millburn, NJ

Duration: 12+ months contract position

Client: Direct Client

Requirements:

· B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field or related field with 5 years’ relevant experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.

· Ability to read/interpret engineering drawings and design documents.

· Excellent technical writing and verbal communication skills.

· Working knowledge of FDA regulations and GMP systems, particularly 21 CFR part 11, 210, 211; and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.

· Strong understanding and operating awareness of working in a pharmaceutical company. Experience in regulatory agency and partner/collaborator inspections.

· Demonstrated ability to problem solve and mediate complex issues. Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.

· Strong communication, leadership and team working skills. Project management capabilities preferred.

· Effective in prioritizing, shows the appropriate sense of urgency around prioritized tasks. Flexibility and ability to prioritize and manage multiple tasks simultaneously.

· Creative thinker in ways in which we can ensure better compliance and systems (A risk-based approach to Quality and Compliance).

· Demonstrated excellence in written and verbal communication. Ability to effectively communicate at all levels in the organization – oral and written.

· Demonstrated ability to work cross-functionally.

· Highly motivated, driven and have a passion to be part of a fast-paced team.

Job Types: Full-time, Contract

Pay: $44.00 - $59.00 per hour

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• Bachelor's (Required)

Experience:

• pharmaceutical or biopharmaceutical: 5 years (Required)
• GPM Manufacturing process: 5 years (Required)
• Remediation/Validation: 5 years (Required)

Work Location: One location

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