Senior Engineering Manager

PSC Biotech • York, PA

2d

About The Position

The Senior Engineering Manager leads the Validation Engineers and Process Engineers at the BioTechnique CDMO site. The role oversees startup, commissioning, qualification, validation, and ongoing operation of process equipment, utilities, and systems to support safe, compliant, and efficient pharmaceutical manufacturing for clinical and commercial products. The manager collaborates across departments and with overseas teams, equipment vendors, contractors, clients, and regulatory or customer auditors. The position also leads engineering and validation activities, supports quality investigations and audit readiness, manages projects and resources, and develops the team. The role works additional hours as needed and performs other duties or responsibilities as required.

Requirements

• Bachelor’s degree or higher in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical field, or equivalent relevant experience.
• More than 10 years of pharmaceutical, biotechnology, or CDMO experience with leadership responsibility; parenteral manufacturing experience, preferably aseptic or sterile manufacturing.
• Strong understanding of sterile injectable manufacturing, engineering systems, and validation lifecycle management.
• Working knowledge of quality systems and regulatory requirements, including 21 CFR Parts 11, 210, and 211, and thorough understanding of cGMPs and pharmaceutical regulatory guidelines.
• Experience supporting FDA inspections, capital projects, equipment startup, and client-facing pharmaceutical operations.
• Strong innovation skills and ability to foster continuous improvement by finding faster, better, and less expensive approaches.
• Demonstrated ability to plan, organize, analyze, and resolve problems; self-directed, resourceful, detail-oriented, and able to handle multiple projects.

Responsibilities

• Oversee startup and ongoing operation of process equipment, utilities, and facility systems supporting sterile manufacturing, ensuring regulatory and industry-standard compliance.
• Work with departments across the site on engineering and validation issues and support equipment troubleshooting.
• Monitor and analyze process performance data and implement corrective actions to maintain reliable operations.
• Develop and manage project timelines, budgets, and resources for new equipment startup.
• Establish and maintain relationships with equipment vendors and contractors.
• Lead and execute commissioning, qualification, and validation activities for equipment, utilities, processes, and systems.
• Ensure validation lifecycle activities, including IQ/OQ/PQ, process validation, and cleaning validation, meet cGMP and regulatory requirements.
• Maintain the Site Validation Master Plan and support development of its electronic version in ACE®.
• Manage site validation execution and revalidation cycles to prevent equipment from becoming overdue.
• Review validation documentation for equipment, processes, and systems.
• Ensure validation and process engineering activities are documented in ACE® or the Kneat Paperless Validation System.
• Maintain compliance with FDA, EU, cGMP, global regulatory, safety, health, and environmental requirements, and promote a safety culture.
• Support quality investigations involving validation or process deviations, GMP issues, system issues, and CAPAs.
• Conduct risk assessments, FMEA, and root-cause investigations for existing and new equipment; review technical and investigation reports as appropriate.
• Support proposed changes to systems, procedures, and methods.
• Support regulatory and customer audit and inspection readiness, whether virtual or onsite.
• Lead, guide, mentor, and support Validation Engineers and Process Engineers; train new Engineering & Validation employees and attend training as needed.
• Coordinate with overseas teams on cGMP documents for internal and client needs.
• Develop and implement process optimization, efficiency improvement, and cost-reduction strategies while maintaining product quality and safety.
• Gather metrics and use KPIs to monitor performance and drive continuous improvement.
• Stay current with industry trends, best practices, and regulatory changes relevant to pharmaceutical manufacturing technology.
• Collaborate with Quality Assurance, Manufacturing, Metrology, Facilities, MSAT, and Supply Chain on new product introductions, technology transfers, and process changes.
• Coordinate site validation activities with involved departments and uphold quality standards for document writing, protocol execution, and quality-event writing and management.
• Support client-facing activities, including audits, technical discussions, and program reviews.
• Support company goals, policies, procedures, GMP, and FDA/EU regulations.
• Work additional hours as needed and perform other duties or responsibilities as required.

Benefits

• Medical, dental, and vision insurance; PSC pays 100% of qualifying employee medical premiums and 50% of qualifying dependent premiums.
• Employee Assistance Program options, basic life insurance, and short- and long-term disability insurance.
• 401(k) and 401(k) matching.
• PTO, sick time, and paid holidays.
• Education assistance.
• Pet insurance.
• Fitness perks and discounted rates.
• Financial perks and discounts.
• Incentive pay/performance agreement as part of the total compensation package.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior