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Manager, Process Engineering

Reference Number: 2770
Location: Southeast

Our client is a diversified healthcare company that is dedicated to improving care through a combination of branded products, generics, devices, technology and services.  They have asked us to assist them in their search for a Manager, Process Engineering.

The Manager, Process Engineering will interact with internal groups to provide technical support during process development, scale-up, technology transfer, and commercialization.  The incumbent will support manufacturing operations to assure uninterrupted product supply.  He/she will provide leadership, direction, and assure a state of compliance for validation activities associated with manufacturing operations.

Major tasks and responsibilities will include:

  • Manages as well as participates in manufacturing and project teams.
  • Interacts with peers including supply chain, QA, RA, R&D, Engineering, QC, and project management to insure reliable Commercial Supply.
  • Advances projects in a timely and cost effective way while maintaining quality.
  • Works with ANDA and NDA Technical Operations to ensure manufacturability of new products as they advance through process development, scale-up, technology transfer, validation, and commercialization.
  • Independently identifies, prevents, and solves technical problems (e.g., Manufacturing issues, product quality issues, customer complaints, etc.).
  • Manages technology transfers for internal product moves as well as to third party manufacturers as required.       
  • Responsible for development and management of departmental budget.
  • Provides leadership, direct support, coaching, and development of direct reports.
  • Provides oversight and recommendations for all process related validation activities to include IQs, OQs, PQs, Cleaning validations, etc.

We seek candidates with the following qualifications:

  • BS in Chemical Engineering, Chemistry, Pharmacy, or related scientific field with a minimum of 9 years of relevant experience in the pharmaceutical industry or related field.
  • Advanced degree (MS or MBA) with a minimum of 7 years of experience.
  • At least 2 years of experience in a Management role is preferred.
  • Familiarity with cGMP, DEA, and FDA regulations and SUPAC and ICH guidelines.
  • Proficiency in a body of information required for the job, e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
  • Understanding of the current pharmaceutical technologies and manufacturing equipment; technology transfer & scale-up, testing, validation, and packaging.
  • Knowledge of requirements for post approval changes, relevant ICH, SUPAC, and current process validation.
  • Knowledge of process development, technology transfer and scale-up, and technical writing.
  • Strong communication skills, and analytical thinking and problem solving.
  • Risk assessment and statistical process control experience is a plus.
  • Must be able to work well in a team-oriented environment.
  • Critical thinking, problem solving, and results oriented.
  • Experience in team building and motivating the team to action, and is able to influence others through indirect means.
  • Ability to organize, prioritize, and successfully complete multiple projects, tasks, and issues in a timely manner.
  • Ability to function independently in periods of supervision’s absence.
  • Domestic and international travel up to 25% may be required.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2770. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.