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Process Engineer-Bulk

Job ID: 7017
Location: Wilmington, OH
# of Openings: 1

Description

Alkermes, Inc. is a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to develop innovative medicines that improve patient outcomes. The company has a diversified portfolio of more than 20 commercial drug products and a substantial clinical pipeline of product candidates that address central nervous system (CNS) disorders such as addiction, schizophrenia and depression.  Headquartered in Dublin, Ireland, Alkermes has an R&D center and US headquarters in Waltham, Massachusetts and manufacturing facilities in Athlone, Ireland, and Wilmington, OH.  For more information, please visit Alkermes’ website at www.alkermes.com .

Job Description:

Support and assist in the manufacture of pharmaceutical products for commercial and clinical supplies.  Scale-up and transfer formulations/processes to production facility, design and recommend equipment purchases, write and execute qualification/validation protocols.  Troubleshoot automated equipment for pharmaceutical formulation and packaging.  Identify and implement process/equipment improvements (utilizing Change Control system) to reduce waste and increase process reliability.

 

Minimum Education & Experience Requirements:

BS degree in Engineering and 1-2 years sterile pharmaceutical experience, or 5+ yrs pharmaceutical engineering experience. 

 

Knowledge/Skills Needed:

 

  • Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as parenteral drug process systems and equipment.
  • Thorough knowledge of automated control systems.
  • Thorough knowledge of computer systems operation and software.
  • Thorough knowledge of cGMP, OSHA, EPA and FDA facility requirements and regulations.
  • Thorough knowledge of chemistry, statistics, equipment design, process control, and process scale-up.
  • Knowledge of sterile pharmaceutical operations and equipment validations.
  • "Hands-on" ability to install and troubleshoot instrumentation and equipment.
  • Ability to troubleshoot and maintain manufacturing systems, equipment and processes.
  • Ability to author high quality technical protocols/reports (Engineering Studies, Validation protocols, summary reports, equipment specifications, and SOPS).
  • Ability to specify and size manufacturing systems, equipment and process equipment.
  • Ability to gown in an aseptic manner for clean room operations.
  • Ability to read, understand and accurately follow company SOPs and guidelines

 

Personal Attributes Needed:  

  • Excellent communication and documentation skills.
  • Excellent organizational skills.
  • Ability to self-manage and prioritize workload.
  • Ability to react quickly to understand and solve problems.
  • Excellent troubleshooting skills.
  • Positive attitude.

 

Physical Requirements:

Ability to lift / move 40lbs. overhead. Ability to team lift up to 100 lbs.  Ability to operate all types of production equipment.  Ability to gown correctly for clean room manufacturing operations.  Ability to read, understand and accurately follow company SOPs and guidelines.  Ability to stand or sit for extended periods of time (up to 2 hours at a time).  Must be able to work in office and manufacturing environment.  Some travel required (< 10%).

 

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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