Director, Manufacturing Engineering

Company: Thermo Fisher Scientific Inc.
Location: High Point
Posted on: May 3, 2025

Job Description:

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety StandardsJob DescriptionHow you will make an impact:The Engineering Director for Pharma Services Group (PSG) will lead the engineering operations and expansion projects of the Biologic Drug Product sterile filling Good Manufacturing Practices (GMP) facility. This position involves leading Engineering, Site Projects, Maintenance, Equipment Validations, Calibrations, Automation, Energy Conservation, and EH&S. The ideal candidate will be a strategic leader, using data to drive decision-making, ensuring GMP compliance, promoting accountability, improving customer experience, and leading changes within the Engineering and Project department.How You'll Make a DifferenceAs a member of the Site Leadership team:

• Lead GMP Plant Site Engineering and Expansion Projects, including recruiting, training, and developing the team.
• Direct operations, maintenance, Commissioning, Qualification and Validation (CQV), spare parts management, planned shutdown and calibrations, ensuring uninterrupted supply of process equipment, clean utilities and black utilities, facilities.
• Develop and lead the engineering budget, prioritising resources to meet compliance and business objectives.
• Collaborate with Thermo Fisher SMEs to implement corporate guidelines and share good practices across sites.
• Guide staff in handling equipment files, technical materials, fixed assets, contracts, energy, and engineering per GMP standards.
• Establish and lead all aspects of calibration systems for measuring instruments and ensure compliance with GMP requirements.
• Coordinate internal and external audits, inspections, and quality system implementation.
• Handle and report equipment accidents, participate in investigations, and recommend corrective actions.
• Lead the maintenance team's activities, including inspections, verification, and corrective actions.
• Lead hiring, onboarding, development, mentoring, and succession planning for engineering staff.
• Ensure the GMP project aligns with the design basis through collaboration with the EPCM firm, enabling seamless commissioning, qualification, and validation (CQV).
• Coordinate environmental, quality, and safety (EHS) compliance during construction and facility engineering to prevent production safety incidents.
• Address safety hazards, equipment selection, configuration, and energy efficiency in design reviews.
• Maintain effective communication with the construction team to monitor progress and lead plant facilities during and post-construction.Key Requirements/QualificationsEducation:
  • Bachelor's/ Master's degree or equivalent experience in Engineering or a related field required.Experience:
    • 20 years of Good Manufacturing Practice (GMP) experience in the pharmaceutical industry. Strong understanding of cGMPs and Engineering compliance requirement for Singapore HSA, EMA and US FDA, customer audits. Master certain technical knowledge in HAVC, Utility and Process Equipment, Water systems, Electrical and Automation etc.Proficiencies:
      • Expertise in internal, corporate, customer and regulatory auditing.
      • Advanced presentation skills for senior executive/board-level audiences.
      • Outstanding skill in establishing positive relationships with teams from different functions, collaborators, and SMEs.
      • Excellence in driving functional, technical, and operational performance.
      • Proficient in solving complex problems, proactive and assertive approach.
      • Agile and resilient in fast-paced settings.
      • Effective conflict resolution skills.
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Keywords: Thermo Fisher Scientific Inc., Cary , Director, Manufacturing Engineering, Executive , High Point, North Carolina