West Pharma Lead Quality Engineering 

United States, Pennsylvania, Radnor Township 

206853858

In this role, you willberesponsible for conducting analytical testing with a focus on performance and functionality testing (force testing) and container closure integrity (CCI) assessments in compliance with Good Manufacturing Practice (GMP) regulations. This role involves method execution, documentation, and collaboration with cross-functional teams to ensure the quality and integrity of pharmaceutical packaging. The ideal candidate will have experience with physical and mechanical testing methodologies, strong analytical skills, and a thorough hands-on understanding of GMP requirements.

• Conduct performance and functionality testing using force-based technique (Instron machine).
• Conduct container closure integrity (CCI) testing using helium leak technique.
• Use instrumentation both qualitatively and quantitatively where appropriate. Independently troubleshoot instrumentation.
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Collaborate with cross-functional teams.
• Willingness to learn and apply new analytical techniques.
• Perform lab investigations, OOS, and OOT as required and resolve problems in the lab.
• Apply required cGMP regulations and follow all policies and procedures.
• Apply internal QA procedures.
• Adhere to established laboratory safety procedures.
• Other duties as assigned.

• Bachelor’s degree or equivalent experience in chemistry, engineering or closely related fields.

• Minimum 3 years of professional experience in a GMP lab environment required
• Experience in pharmaceutical or packaging field and implementing laboratory training programs required

• Working knowledge and experience with at least one of the skills below
  • Physical / mechanical testing such as Instron or Zwick
  • Container closure integrity (CCI) via helium leak
• Experience in analytical testing in GMP environment.
• Ability to work independently, with minimal guidance and an attention to detail
• Able to comply with all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
• Able to comply with the company’s safety policy at all times.
• Able to follow directions, prioritize tasks, and work independently.
• Must have excellent interpersonal, written and verbal communication skills.
• Must be proficient in Microsoft Office tools and capable to learn other software programs.
• Able to review regulatory code and learn safety standards.

• Physical:
  • Must be able to stand for long periods of time.
  • Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.
• Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures).
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Read and interpret data, information and documents.