Program Manager of Engineering

Description

Job Purpose/Summary: 

The Program Manager, Engineering will lead and coordinate cross-functional engineering and technical initiatives across multiple projects in a regulated pharmaceutical manufacturing environment. This role is responsible for managing capital projects, equipment upgrades, process improvements, and facility modifications, ensuring all programs are executed in compliance with cGMP, FDA regulations, and corporate quality standards.

Essential Duties and Responsibilities:

• Program & Project Management: Lead the planning, execution, and delivery of engineering projects, including facility      expansions, equipment installations, automation upgrades, and process optimization.
• Regulatory Compliance: Ensure all engineering  activities comply with cGMP, FDA, DEA, OSHA, and environmental regulations. Support audits and inspections by regulatory agencies.
• Cross-Functional Leadership: Collaborate with Quality Assurance, Production, Validation, Maintenance, EHS, and Supply Chain      teams to deliver integrated solutions that meet business and compliance requirements.
• Capital Project Management: Manage budgets, schedules, vendor selection, procurement, and contractor oversight for      capital improvement projects.
• Documentation & Validation: Oversee the creation and approval of engineering documentation, including URS, FAT/SAT,      IQ/OQ/PQ protocols, and final reports.
• Risk & Change Management: Identify risks, propose mitigations, and manage change control processes to ensure safe and      compliant execution of engineering activities.
• Process Improvement: Drive continuous improvement initiatives to enhance efficiency, reduce downtime, and ensure product      quality and manufacturing reliability.

Required Qualifications: 

• Bachelor's degree in Mechanical, Chemical, Electrical Engineering or related technical field (Master’s degree preferred)
• 5–10 years of engineering/project management experience in a pharmaceutical or regulated manufacturing environment
• Strong knowledge of cGMP, FDA, and ICH guidelines
• Proven experience managing cross-functional capital and process engineering projects
• Familiarity with clean room design, HVAC systems, process utilities, and manufacturing equipment 
• Deep knowledge validation, and engineering documentation practices.
• Strong experience with process scale-up, tech transfer, and equipment qualification.
• Proven ability to lead cross-functional teams and manage multiple complex projects.
• Excellent problem-solving, communication, and stakeholder management skills.

Preferred Qualifications:

• PMP certification or equivalent project management training; Lean Six Sigma certification
• Experience with generic drug production, and sterile manufacturing
• Proficiency in Program Management tools, AutoCAD, and engineering documentation systems
• Familiarity with automation systems, MES, and digital manufacturing tools.
• Experience in facility design and expansion projects.

Working Conditions / Physical Requirements:

• On-site in a regulated pharmaceutical manufacturing facility; May require occasional travel
• This position requires lifting (up to 40 lbs.), standing, sitting and walking throughout the facility.