Job DescriptionThe Senior Engineering Manager is responsible for leading the Validation Engineers and Process Engineers at the BioTechnique CDMO site. This role oversees the startup, commissioning, qualification, validation, and continuous operation of process equipment, utilities, and systems to ensure safe, compliant, and efficient pharmaceutical manufacturing operations supporting clinical and commercial products.
- Oversee the startup and continuous operation of process equipment, utilities, and facility systems supporting sterile manufacturing operations, ensuring compliance with regulatory requirements and industry standards.
- Work with multiple departments on engineering and validation issues across the site and support equipment troubleshooting.
- Monitor and analyze process performance data, implementing corrective actions as needed to maintain consistent and reliable operations.
- Develop and manage project timelines, budgets, and resources for new equipment startup, ensuring projects are completed on time and within budget.
- Establish and maintain strong relationships with equipment vendors and contractors.
- Lead and execute Commissioning, Qualification, and Validation (CQV) activities for equipment, utilities, processes, and systems across the site.
- Ensure validation lifecycle activities (e.g., IQ/OQ/PQ, process validation, cleaning validation) meet cGMP and regulatory requirements.
- Manage the current state of the Site Validation Master Plan and support development of the electronic Site Validation Master Plan in ACE®.
- Perform and manage validation execution activities at the site to ensure that no equipment goes overdue with its revalidation cycle.
- Review validation documentation for equipment, processes, and systems.
- Ensure that all validation and process engineering activities are documented in ACE® or Kneat Paperless Validation System.
- Maintain compliance with FDA, EU, cGMP, and global regulatory standards, as well as all relevant safety, health, and environmental regulations, promoting a culture of safety within the team.
- Support quality investigations of validation/process deviations, GMP issues, system issues, and CAPAs.
- Conduct risk assessments, failure mode and effects analysis (FMEA), and root cause investigations to identify and mitigate potential issues with existing and new equipment at the site.
- Review technical and investigation reports as appropriate.
- Provide support for proposed changes to systems, procedures, and methods, as appropriate.
- Support audit and inspection readiness, including regulatory or customer audits, whether virtual or onsite.
- Lead and manage a team of Validation Engineers and Process Engineers, providing guidance, mentorship, and support to ensure team success.
- Train new employees in the Engineering & Validation department and attend training sessions as needed to promote continuous improvement.
- Work with overseas teams to coordinate preparation of cGMP documents to meet internal company needs as well as BioTechnique client needs.
- Develop and implement strategies for process optimization, efficiency improvements, and cost reduction while maintaining product quality and safety.
- Gather metric information and utilize KPIs to monitor performance and drive continuous improvement in areas of responsibility.
- Stay current with industry trends, best practices, and regulatory changes to ensure the company remains at the forefront of pharmaceutical manufacturing technology.
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Metrology, Facilities, MSAT, and Supply Chain, to support new product introductions, technology transfers, and process changes.
- Coordinate validation activities at the site with all other departments involved, ensuring BioTechnique is held to high quality standards for validation activities (including but not limited to document writing, protocol execution, and quality event writing and management).
- Support client-facing activities, including audits, technical discussions, and program reviews.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA/EU regulations.
- Work additional hours as needed and perform other duties or responsibilities, as required.
Requirements- Bachelor's degree or higher in Engineering, Pharmaceutical Sciences, Life Sciences, or related technical field, or equivalent relevant experience.
- More than 10 years of pharmaceutical, biotechnology, or CDMO experience with leadership responsibility, preferably in a parenteral manufacturing environment (aseptic/sterile manufacturing).
- Strong understanding of sterile injectable manufacturing, engineering systems, and validation lifecycle management.
- Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211), with a thorough understanding of cGMPs and regulatory guidelines for the pharmaceutical industry.
- Experience supporting FDA inspections, capital projects, equipment startup, and client-facing pharmaceutical operations.
- Show strong innovation skills to reimagine how to do things faster, better, and less expensively, and to foster a culture of continuous improvement.
- Demonstrated ability to plan, organize, analyze, and resolve problems; self-directed, resourceful, detail-oriented, and able to handle multiple projects.
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more
- 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
This position is eligible for an incentive pay/performance agreement as part of the total compensation package
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