GMP Sterile Manufacturing Operations Lead

MSD Malaysia; West Point (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Our Company in West Point, PA seeks an Operations Manager on 1st Shift for the Sterile Liquids Pilot Plant. You will lead a team of manufacturing professionals, ensure safe and compliant execution, and drive continuous improvement to meet schedules and quality targets.

Responsibilities include daily supervision, risk mitigation, audit readiness, and partnership with Quality, Engineering, and regulatory functions to uphold aseptic manufacturing standards.

Qualifications

• Bachelor’s degree in science, engineering or another technical field.
• Minimum 3 years of leadership experience within Manufacturing, Quality, Technical Operations, Engineering, Validation, Supply Chain, or related life science operations.
• Demonstrated experience working in a regulated GMP environment.
• Proven experience leading teams and delivering results through others.
• Strong knowledge of current Good Manufacturing Practice regulations, Good Documentation Practices, and quality systems.
• Demonstrated experience in supporting the investigation of manufacturing events, deviations, non-conformances, audits, and operational issues.
• Ability to identify systemic issues, assess risk, and implement effective corrective actions.
• Experience working across Quality, Manufacturing, Engineering, and Technical Operations organizations.

Responsibilities

• Provide visible, first-line supervision of manufacturing operations and personnel.
• Set daily priorities, assign work, coordinate support resources, and ensure effective shift handoffs.
• Lead tier meetings, communicate schedule and performance expectations, and escalated safety, quality, staffing, or supply risks.
• Timely review and approve manufacturing and compliance documentation as authorized by procedures.
• Proactively identify and recommend capital improvements for the shop floor, aligned with operational excellence and compliance objectives.
• Champion a proactive quality culture that prioritizes patient safety, product quality, data integrity, and regulatory compliance.
• Serve as a quality advocate by ensuring manufacturing activities comply with current Good Manufacturing Practice, regulatory requirements, site procedures, and quality standards, with a particular focus on aseptic behaviors.
• Maintain a state of inspection readiness and support all audits.
• Demonstrate strong knowledge of regulatory expectations, data integrity principles, quality risk management, and Good Documentation Practices.
• Ensure safe, compliant, and reliable execution of manufacturing operations while meeting production schedules and customer requirements.
• Monitor shift and area performance metrics and lead actions to address gaps.
• Identify and implement opportunities to improve process robustness, cycle time, productivity, deviation reduction, and operational efficiency.
• Make and elevate risk-informed decisions consistent with procedures and quality requirements.
• Foster a culture of operational excellence through structured problem solving and continuous improvement initiatives.
• Support value stream improvements and business process optimization efforts using Lean Manufacturing and MPS methodologies.
• Promote behaviors that improve process stability, employee engagement, and organizational effectiveness.
• Develop a high-performing organization through coaching, talent development, and performance management.
• Create an inclusive environment that embodies our Company Values and Enterprise Leadership Skills.

Skills

Leadership

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Lean manufacturing

Education

Bachelor's degree in science, engineering or a technical field

Job description

Our Company in West Point, PA seeks an Operations Manager on 1st Shift for the Sterile Liquids Pilot Plant. You will lead a team of manufacturing professionals, ensure safe and compliant execution, and drive continuous improvement to meet schedules and quality targets.

Responsibilities include daily supervision, risk mitigation, audit readiness, and partnership with Quality, Engineering, and regulatory functions to uphold aseptic manufacturing standards.