Pharmaceutical Manufacturing Engineer

2 months ago

Thousand Oaks, United States EPITEC Full time

Seeking a Manufacturing Senior Engineer to support manufacturing activities and the operation of cGMP equipment and facilities at our Thousand Oaks site. This role works closely with automation, maintenance, project management, and corporate engineering teams to ensure the reliability and performance of critical equipment while adhering to safety and quality compliance standards.

Key Responsibilities:

  • Lead and model leadership behaviors to foster a positive and collaborative work environment.
  • Ensure equipment reliability and support capital projects to meet business objectives.
  • Assist in identifying key quality parameters for new equipment and facility modifications.
  • Recommend design modifications to enhance quality, safety, and operational efficiency.
  • Develop and implement commissioning strategies based on risk assessments and project requirements.
  • Oversee the development of validation protocols and ensure compliance with cGMP standards.
  • Manage and evaluate the performance of contract resources and verification deliverables.
  • Serve as the liaison between engineering and quality assurance during all project phases.
  • Ensure all work is conducted with safety compliance and documented in accordance with cGMP practices.
  • Review and approve commissioning reports, maintenance procedures, and parts to improve productivity.

Additional Responsibilities:

  • Lead or participate in cross-functional teams for root cause analysis and continuous improvement initiatives.
  • Support Lean and process improvement efforts to optimize cost, safety, quality, and speed.
  • Provide technical support for manufacturing and maintenance teams as needed.
  • Mentor project teams and engineers, guiding them with risk-based approaches.
  • Ensure equipment calibration, maintenance, and validation are compliant during regulatory inspections.
  • Contribute to internal audits and work closely with quality assurance to meet compliance standards.
  • Support the development of business performance metrics.

Basic Qualifications:

  • Doctorate OR Master’s + 3 years of experience OR Bachelor’s + 5 years of experience OR Associate’s + 10 years of experience OR High school diploma/GED + 12 years of experience in engineering/manufacturing.

Preferred Qualifications:

  • Bachelor's degree in Engineering or a related field.
  • 7+ years of relevant experience, with at least 5 years in a manufacturing/operations environment.
  • Direct experience in regulated environments (FDA, OSHA, EPA).
  • Expertise in cGMP practices and pharmaceutical/biotech production processes.
  • Experience with risk-based verification in GMP process equipment and automation projects.
  • Strong knowledge of process equipment, automation systems (e.g., Delta V, Rockwell), and industry trends.
  • Excellent communication and technical writing skills.
  • Experience in process improvement methodologies (e.g., Lean, Six Sigma) and collaborative team environments.

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