Associate Director of Engineering--Pharmaceuticals

Location: Charlotte, North Carolina
Date Posted: 07-16-2018
We are looking for an Associate Director of Engineering to play a key role in a pharmaceuticals manufacturing facility. This position will lead a team of individuals supporting qualification of equipment, facilities, and utilities. In addition, the Associate Director of Engineering will be responsible for leadership of highly complex compliance projects and initiatives such as New Product Introduction and the Cleaning Validation Program. This role will require an experienced people manager, with technical knowledge of pharmaceutical aseptic filling operations and equipment, as well as solid dosage operations and equipment.

Job Description

  • Provide mentorship and direction to staff on execution of the Qualification/Validation Lifecycle.
  • Complete capital projects (new projects/project expansions/up-gradation of existing facilities) on time and within the approved budget.
  • Develop a strong documentation package, involving form conceptual study to various phases of project like basic engineering, detail engineering, pre-commissioning / commissioning of equipment.
  • Preparation for various regulatory inspections/audits and active participation during audits, as needed.
  • Workload forecasting and ensure that effective work processes/procedures are implemented and followed by all the team members.
  • Conduct regular project review meetings with direct reports, cross-functional teams, and vendors to manage within project timelines.
  • Develop Block Flow Diagrams, Process Flow Diagrams, Piping and instrumentation Diagrams, Mass and utility balances, and safety analysis of biopharmaceutical processes.
  • Provide conceptual, detailed design, project planning, and execution and qualification of biopharmaceutical facilities as per cGMP requirements.
  • Process valve matrix, process sequence logics, functional design specification (FDS), process control sequences, and CIP/SIP sequences, etc.
  • Develop / review URS, Tendering, preparation of technical comparisons, DQ, FAT, recipient of equipment, SAT, commissioning, qualification and validation.


  • B.S in Chemical, Biochemical, or Mechanical Engineering or related discipline required.
  • M.S., M.B.A. or other advanced technical or business degree is desirable.
  • Minimum of ten (10) years of relevant experience in the pharmaceutical industry.
  • Thorough understanding of aseptic filling unit operations and controls, as well as drug product process validation is highly desired.
  • Resource forecasting experience is also highly desired.
Knowledge & Skills:
  • Proficient in AutoCAD, MS Office; knowledge of database management and statistical analysis.
  • Excellent verbal, written and interpersonal communication skills. 
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