Senior Engineering Manager

PSC Biotech • York, PA

2d

About The Position

BioTechnique is a sterile injectable full-service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services, from IND applications through commercial-scale production. Its services include formulation and compounding, fill-finish, and lyophilization.

The Engineering/Validation Manager leads the site’s Validation Engineers and Process Engineers. The position 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 role works across departments and with vendors, contractors, overseas teams, clients, and cross-functional partners to manage engineering and validation activities, maintain regulatory compliance, and support continuous improvement.

The manager also provides team leadership, mentorship, and training; supports audit and inspection readiness; and contributes to new product introductions, technology transfers, process changes, and client-facing activities. Additional hours may be required, and other duties may be assigned.

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 or aseptic/sterile manufacturing experience is preferred.
• Strong understanding of sterile injectable manufacturing, engineering systems, and validation lifecycle management.
• Working knowledge of quality systems and regulatory requirements, including 21 CFR Part 11/210/211, 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, including the ability to find faster, better, and less expensive ways of working and foster continuous improvement.
• Ability to plan, organize, analyze, and resolve problems; self-directed, resourceful, detail-oriented, and able to manage multiple projects.

Nice To Haves

• Experience in a parenteral manufacturing environment, including aseptic or sterile manufacturing.

Responsibilities

• Oversee startup and ongoing operation of process equipment, utilities, and facility systems supporting sterile manufacturing.
• Coordinate with departments across the site to address engineering and validation issues and support equipment troubleshooting.
• Analyze process performance data and implement corrective actions to maintain reliable operations.
• Develop and manage project timelines, budgets, and resources for new equipment startups.
• Build 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.
• Manage the Site Validation Master Plan and support development of its electronic version in ACE®.
• Manage site validation execution and prevent equipment from going overdue for revalidation.
• 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, and applicable safety, health, and environmental requirements; promote a culture of safety.
• Support quality investigations involving validation or process deviations, GMP issues, system issues, and CAPAs.
• Conduct risk assessments, FMEA, and root-cause investigations to identify and mitigate equipment-related issues.
• Review technical and investigation reports as appropriate.
• Support proposed changes to systems, procedures, and methods as appropriate.
• Support regulatory and customer audit and inspection readiness, including virtual and onsite activities.
• Lead, mentor, and support Validation Engineers and Process Engineers.
• Train new Engineering & Validation employees and attend training sessions as needed.
• Coordinate with overseas teams on cGMP document preparation for company 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 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 and procedures, Good Manufacturing Practices, and FDA/EU regulations.
• Work additional hours as needed and perform other required duties or responsibilities.

Benefits

• Medical, dental, and vision coverage; PSC pays 100% of qualifying employee medical premiums and 50% for qualifying dependent premiums.
• Employee Assistance Program options, basic life insurance, short- and long-term disability insurance, and other insurance options.
• 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.
• Eligible for incentive pay/performance agreement as part of the total compensation package.

What This Job Offers

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