Senior Director, Pharmaceutical Process Engineering

Skills Alliance

Indiana (PA)

On-site

USD 190,000 - 230,000

Full time

3 days ago
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Job summary

Skills Alliance in the United States is seeking a Director of Process Engineering to lead process engineering activities supporting pharma manufacturing, scale-up and commercialization. This role combines strategic leadership with hands-on technical expertise to guide cross-functional teams ensuring compliant, reliable, and scalable processes.

The position emphasizes driving process improvements, managing capital projects and supporting regulatory inspections in a fast-paced, highly regulated

Qualifications

  • Bachelor’s degree in Chemical/Mechanical/Process Engineering or related field.
  • 15+ years experience in pharmaceutical or similarly regulated environments.
  • 10+ years engineering leadership experience.
  • Experience with GMP, process validation, PPQ, equipment qualification and compliance.
  • Experience in radiopharmaceutical or radioactive materials would be valuable.

Responsibilities

  • Lead process engineering activities across pharmaceutical manufacturing operations.
  • Support development, scale-up, technology transfer and commercialization.
  • Lead process validation, PPQ and continued process verification.
  • Drive improvements in process performance and equipment reliability.
  • Oversee capital equipment projects from selection to qualification.
  • Collaborate with Manufacturing, Quality, Validation and Technical Operations.
  • Ensure GMP, safety and regulatory compliance.
  • Recruit and develop engineering personnel.

Skills

Strategic engineering leadership
Hands-on technical expertise
Process engineering
Capital projects management
GMP/compliance knowledge
Cross-functional collaboration
Technical writing
Regulatory inspections support

Education

Bachelor’s degree or higher in Chemical/Mechanical/Process Engineering

Job description

Skills Alliance in the United States is seeking a Director of Process Engineering to lead process engineering activities supporting pharma manufacturing, scale-up and commercialization. This role combines strategic leadership with hands-on technical expertise to guide cross-functional teams ensuring compliant, reliable, and scalable processes.

The position emphasizes driving process improvements, managing capital projects and supporting regulatory inspections in a fast-paced, highly regulated

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