Sterile Facilities & Engineering Manager

Penn Life Sciences; Pennsylvania; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

401(k) matching

Paid Time Off

Medical insurance

Dental insurance

Vision insurance

Life insurance

Tuition reimbursement

Childcare expense reimbursement

Job summary

Penn Life Sciences is seeking a Manager, Facilities & Engineering to lead integrated facilities, engineering, utilities, maintenance, commissioning, qualification, and validation for sterile pharmaceutical manufacturing.

The role provides hands-on technical and managerial leadership for critical infrastructure, capital projects, and the site validation program, driving regulatory readiness from pre-commercial to commercial operations.

Qualifications

• Extensive experience in cGMP pharmaceutical environments with sterile operations.
• Demonstrated leadership of cross-functional technical teams and projects.
• Knowledge of validation lifecycle and regulatory expectations.

Responsibilities

• Lead and coordinate facilities, engineering, utilities, maintenance, commissioning, qualification and validation activities.
• Develop and manage Validation Master Plan, schedules, and lifecycle requirements.
• Oversee qualification and validation for sterile manufacturing equipment and systems.
• Support process validation, cleaning validation, sterilization validation and related activities.
• Lead investigations of equipment failures and validation deviations.

Skills

cGMP-regulated environment

People management

Project management

Sterile manufacturing knowledge

Validation concepts

Education

Bachelor’s degree in Engineering or related field

Advanced degree preferred

Tools

GAMP 5

Job description

Penn Life Sciences is seeking a Manager, Facilities & Engineering to lead integrated facilities, engineering, utilities, maintenance, commissioning, qualification, and validation for sterile pharmaceutical manufacturing.

The role provides hands-on technical and managerial leadership for critical infrastructure, capital projects, and the site validation program, driving regulatory readiness from pre-commercial to commercial operations.