Sr. Process Engineer

PCI Pharma Services•San Diego, CA

About The Position

Designs and optimizes pharmaceutical and biopharmaceutical manufacturing processes to improve efficiency and yield. Supports manufacturing operations, mentors junior engineers, and leads technical assessments and process improvement and scale-up projects through successful completion. The role includes designing and specifying processes and manufacturing equipment systems, evaluating existing systems for continuous improvement, reviewing technical documents, researching and implementing new technologies, documenting system changes under change management procedures, and traveling between facilities to support manufacturing processes. Requires regular and reliable attendance on a full-time basis or in accordance with the posted schedule, professional conduct with internal and external business associates, and alignment with PCI’s cultural values and department and company goals.

Requirements

  • Bachelor’s degree in Bioengineering, Chemical Engineering, Electrical Engineering, Industrial Engineering, Mechanical Engineering, or a similar field, or equivalent work experience.
  • At least 8 years of relevant experience.
  • At least 6 years of cGMP experience.
  • Advanced knowledge of manufacturing processes.
  • Mastery of process flow and troubleshooting.
  • Advanced understanding of GMP regulations and requirements.

Responsibilities

  • Design and specify processes and manufacturing equipment systems.
  • Evaluate existing systems for continuous improvement.
  • Provide in-depth technical review of documents.
  • Research new technologies and implement new or upgraded systems.
  • Document system changes according to change management procedures.
  • Travel between facilities to support manufacturing processes.
  • Support manufacturing operations and mentor junior engineers.
  • Lead technical assessments and process improvement and scale-up projects through successful completion.
  • Exhibit professional behavior with internal and external business associates and align daily actions with department goals and company culture.

Benefits

  • Paid time off
  • Health insurance coverage, including dental and vision
  • Flexible spending account
  • 401(k)
  • Eligibility for an annual performance bonus
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