Director, Manufacturing Engineering Position Available In Guilford, North Carolina

Job Description:

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherenceto all Good Manufacturing Practices (GMP) Safety StandardsJobDescriptionHow you will make an impact:

The Engineering Director forPharma Services Group (PSG) will lead the engineering operationsand expansion projects of the Biologic Drug Product sterile fillingGood Manufacturing Practices (GMP) facility. This position involvesleading Engineering, Site Projects, Maintenance, EquipmentValidations, Calibrations, Automation, Energy Conservation, andEH&S. The ideal candidate will be a strategic leader, usingdata to drive decision-making, ensuring GMP compliance, promotingaccountability, improving customer experience, and leading changeswithin the Engineering and Project department.

How You’ll Make aDifferenceAs 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, Qualificationand Validation (CQV), spare parts management, planned shutdown andcalibrations, ensuring uninterrupted supply of process equipment,clean utilities and black utilities, facilities. Develop and lead the engineering budget, prioritising resourcesto meet compliance and business objectives. Collaborate with Thermo Fisher SMEs to implement corporateguidelines and share good practices across sites. Guide staff in handling equipment files, technical materials,fixed assets, contracts, energy, and engineering per GMPstandards. Establish and lead all aspects of calibration systems formeasuring instruments and ensure compliance with GMPrequirements. Coordinate internal and external audits, inspections, andquality system implementation. Handle and report equipment accidents, participate ininvestigations, and recommend corrective actions. Lead the maintenance team’s activities, including inspections,verification, and corrective actions. Lead hiring, onboarding, development, mentoring, and successionplanning for engineering staff. Ensure the GMP project aligns with the design basis throughcollaboration with the EPCM firm, enabling seamless commissioning,qualification, and validation (CQV). Coordinate environmental, quality, and safety (EHS) complianceduring construction and facility engineering to prevent productionsafety incidents. Address safety hazards, equipment selection, configuration, andenergy efficiency in design reviews. Maintain effective communication with the construction team tomonitor progress and lead plant facilities during andpost-construction.

Key Requirements/QualificationsEducation:

Bachelor’s/ Master’s degree or equivalent experience inEngineering or a related field required.

Experience:

20 years of Good Manufacturing Practice (GMP) experience in thepharmaceutical industry. Strong understanding of cGMPs andEngineering compliance requirement for Singapore HSA, EMA and USFDA, customer audits. Master certain technical knowledge in HAVC,Utility and Process Equipment, Water systems, Electrical andAutomation etc.

Proficiencies:

Expertise in internal, corporate, customer and regulatoryauditing. Advanced presentation skills for senior executive/board-levelaudiences. Outstanding skill in establishing positive relationships withteams from different functions, collaborators, and SMEs. Excellence in driving functional, technical, and operationalperformance. Proficient in solving complex problems, proactive and assertiveapproach. Agile and resilient in fast-paced settings. Effective conflict resolution skills. #J-18808-Ljbffr