Engineering Director – Aseptic Manufacturing

Penta Search Group; Philadelphia (Philadelphia County); On-site; USD 180,000 - 240,000; Full time

Job summary

Penta Search Group is supporting a global pharmaceutical organization by recruiting an Engineering Director to lead a major aseptic manufacturing expansion. The role is initially based in Philadelphia, PA, and will coordinate with engineering and project teams to deliver world-class sterile manufacturing solutions.

You will shape equipment and systems, work with suppliers, ensure regulatory compliance, and guide qualification through to manufacturing readiness.

Qualifications

• Bachelor's degree in an engineering discipline required.
• 15+ years of engineering experience in pharma/biopharma manufacturing.
• Experience with aseptic/sterile drug product manufacturing.
• Experience delivering complex manufacturing investment projects.
• Knowledge of cGMP and regulatory expectations for aseptic operations.
• Proven leadership of engineering professionals.

Responsibilities

• Lead engineering decisions for new aseptic manufacturing capabilities.
• Provide technical direction across process equipment, systems, and facilities.
• Oversee design development, equipment selection, and implementation with partners.
• Ensure solutions meet sterile manufacturing regulatory requirements.
• Drive qualification, start-up, and manufacturing readiness of equipment.
• Mentor and develop engineering teams and establish technical standards.
• Collaborate with manufacturing, quality, safety, procurement, and project teams.
• Guide relocation and transition planning for multi-site manufacturing investments.

Skills

Aseptic manufacturing

Sterile drug product manufacturing

Biologics manufacturing

Process engineering leadership

Regulatory compliance (cGMP)

Cross-functional leadership

Facility investment project delivery

Qualification/start-up guidance

Engineering team mentoring

Education

Bachelor's degree in Engineering

Job description

Penta Search Group is supporting a global pharmaceutical organization with the appointment of an experienced Engineering Director to play a key role in the development of significant new manufacturing capacity.

We are interested in speaking with senior engineering leaders who have built their careers around aseptic manufacturing, sterile drug product operations and biologics, particularly those who have helped deliver new facilities, major expansions or complex manufacturing investment programs.

This is a highly visible position combining technical engineering leadership, project delivery and team leadership.

What You'll Be Doing

You will act as a senior engineering authority within a major manufacturing investment, helping translate future manufacturing requirements into practical, compliant and reliable engineering solutions.

Your responsibilities will include:

• Leading engineering decisions associated with new aseptic manufacturing capabilities.
• Providing technical direction across process equipment, manufacturing systems and supporting facility infrastructure.
• Working with engineering partners and equipment suppliers during design development, equipment selection and implementation.
• Ensuring engineering solutions are appropriate for highly regulated sterile manufacturing operations.
• Challenging designs and proposed technical solutions to ensure they are safe, compliant, practical and capable of supporting future manufacturing requirements.
• Supporting equipment and systems as they move from engineering and installation into qualification and manufacturing readiness.
• Troubleshooting complex technical issues and providing clear direction when engineering challenges arise.
• Working closely with manufacturing, technical operations, quality, safety, procurement and project teams throughout the program.
• Helping maintain alignment between engineering execution and the operational requirements of the future manufacturing organization.
• Providing leadership and development to other engineering professionals and helping establish strong technical standards across the team.

What We're Looking For

This is a senior-level appointment requiring substantial experience within regulated pharmaceutical or biopharmaceutical manufacturing.

We would particularly like to hear from candidates who offer:

• Approximately 15+ years of relevant engineering experience within pharmaceutical or biopharmaceutical manufacturing.
• Extensive exposure to aseptic/sterile drug product manufacturing.
• Experience supporting biologics or other large molecule manufacturing operations.
• A strong process engineering background combined with experience delivering complex manufacturing investment projects.
• Experience with the design and implementation of equipment and systems used within sterile manufacturing environments.
• Strong knowledge ofcGMPand the regulatory expectations associated with aseptic operations.
• Practical experience supporting equipment and manufacturing systems through qualification, start-up and manufacturing readiness.
• Experience contributing to the delivery of new facilities, major facility expansions or significant manufacturing modernization programs.
• Previous responsibility for leading and developing engineering professionals.
• The ability to operate effectively across engineering, manufacturing, quality and other technical functions.
• Strong judgement and problem-solving capability when dealing with complex technical issues.
• A Bachelor's degree in an appropriate engineering discipline.
• Experience with new-build pharmaceutical manufacturing projects would be particularly attractive.

Location

The role will initially be based in Philadelphia, Pennsylvania, where the successful candidate will work closely with the engineering and project organization during the current phase of the program.

The position will ultimately transition to the new manufacturing location in North Carolina as the project moves toward start-up. Candidates should therefore be comfortable with the requirement to relocate at a later stage.

Full details regarding the longer-term location, transition timeline and relocation arrangements will be discussed directly with candidates during the recruitment process.