Job Description

DURATION: 12 MONTHS

 JOB RESPONSIBILITIES: Pharm Ops and Clinical Supply – Engineer • Develop ‘Qualification Periodic Review Assessments’ for qualified equipment. • Coordination of the procurement of new equipment. Manage all elements of work inclusive of but not limited to coordinating meetings between vendors and Merck SMEs, authoring appropriate documentation and attending acceptance testing. • Communicate status/metrics and escalate of issues associated with execution of activities. • Remain compliant to all safety and GMP requirements and trainings.

QUALIFICATIONS: • B.S. in Chemical engineering, mechanical engineering, or related discipline and minimum of 3 years of experience working in GMP drug substance/product facilities.

• Experience with: o Development of Standard Operating Procedures for pharmaceutical processing equipment. o Commissioning, qualification and validation of GMP process equipment and associated documentation requirements. o Procurement of new equipment and associated milestones such as authoring URSs and attending SAT or FATs.

• Ability to work independently and as part of a team, self-motivated, adaptable, and a positive attitude. Strong project management skills and ability to manage multiple project timelines.

• Strong computer, scientific, and organizational skills. Excellent communication (oral and written) and attention to detail

• Preferred experience with: o Complex oral solid dosage or sterile pharmaceutical processing equipment and associated utility systems. o Data acquisition systems associated with pilot scale process equipment o Facility start-up and new equipment introduction

Company Description

We place top talent through our divisions: Technology, Staffing, Professionals, Talent Digitalization, and Pyramid Academy. Our flexible staffing options include contract, contract-to-hire, direct hire, and SOW/Statement of Work. We deliver top talent to our clients by combining the use of the latest technology with the subject-matter expertise that our seasoned team of recruiters brings to the process. With the integration of smart sourcing tools, machine learning, and AI/Artificial Intelligence into our screening process across the organization; we evaluate a large volume of candidates to find the most suitable talent.