Director of Process Engineering

Skills Alliance; Indiana (PA); On-site; USD 190,000 - 230,000; Full time

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

The Director of Process Engineering will lead process engineering activities supporting the manufacture, scale-up and commercialisation of pharmaceutical products.

This individual will be responsible for ensuring manufacturing processes, equipment and facilities are robust, reliable, compliant and capable of supporting current and future production requirements.

The position requires a combination of strategic engineering leadership and hands-on technical expertise, working closely with Manufacturing, Quality, Validation, Technical Operations, Maintenance and other cross-functional teams.

Key Responsibilities

• Provide leadership and technical direction for process engineering activities across pharmaceutical manufacturing operations.
• Support the development, scale-up, technology transfer and commercialisation of manufacturing processes.
• Lead engineering support for process validation, PPQ and continued process verification activities.
• Drive improvements in manufacturing processes, equipment performance, reliability and operational efficiency.
• Provide engineering leadership for the introduction, qualification and validation of new manufacturing equipment.
• Lead and support capital projects, including equipment selection, installation, commissioning and qualification.
• Partner closely with Manufacturing, Quality, Validation and Technical Operations to troubleshoot complex process and equipment issues.
• Establish and monitor engineering performance metrics and identify opportunities for continuous improvement.
• Support investigations, deviations, CAPAs and change controls from an engineering perspective.
• Ensure appropriate engineering documentation, procedures and technical standards are developed and maintained.
• Support equipment lifecycle management, preventative maintenance and reliability programmes.
• Work with procurement and external vendors on equipment selection, technical specifications and project delivery.
• Provide technical expertise during regulatory inspections and internal/external audits.
• Ensure engineering activities comply with applicable GMP, regulatory, safety and quality requirements.
• Recruit, develop and lead engineering personnel while building strong technical capabilities across the organisation.
• Support operations involving radioactive materials, ensuring appropriate engineering controls and operational standards are maintained.

Candidate Profile

The successful candidate will ideally have:

• Bachelor’s degree or higher in Chemical Engineering, Mechanical Engineering, Process Engineering or a related engineering discipline.
• Approximately 15+ years of experience within pharmaceutical or similarly regulated manufacturing environments.
• Significant experience in process engineering within commercial pharmaceutical manufacturing.
• Approximately 10+ years of engineering leadership or management experience.
• Strong knowledge of GMP manufacturing, process validation, PPQ, equipment qualification and engineering compliance.
• Experience supporting the commercialisation and scale-up of pharmaceutical manufacturing processes.
• Demonstrated experience delivering significant capital equipment and engineering projects.
• Strong understanding of manufacturing equipment, process controls, automation and reliability.
• Experience leading multidisciplinary engineering teams and working across Manufacturing, Quality, Validation and Technical Operations.
• Strong technical writing and documentation capabilities.
• Ability to operate effectively within a fast-paced, highly regulated manufacturing environment.
• Experience within radiopharmaceutical, nuclear medicine or radioactive-material manufacturing would be particularly valuable.

Ideal Background

This opportunity would suit a senior engineering leader who has operated within complex pharmaceutical manufacturing environments and combines process engineering depth with strong people leadership.

Experience within radiopharmaceutical manufacturing, sterile manufacturing, biologics, API manufacturing or other highly controlled production environments would be particularly relevant.

The successful individual should be comfortable operating at both a strategic and operational level — setting the engineering direction while remaining close enough to manufacturing operations to solve technical problems and drive execution.