Job Description

Production Planning and Execution

• Ensure all batch documentation, logs, forms, and labels are approved/available ahead of manufacturing need dates
• Escalate unmet batch requirements to the Operational Coach and lead re-weigh documentation and activities
• Release production orders, update SAP dates, and perform timely Goods Receipt (GR) and confirmations
• Manage end-to-end batch release and maintain data integrity across records

Compliance and Quality Systems

• Meet departmental global compliance metrics across Deviations, CAPA, Change Control, and Audits
• Lead and support event investigations and CAPA actions; drive effective change management
• Support and participate in compliance audits (housekeeping, internal, regulatory, divisional) and track CAPAs to closure
• Maintain adherence to Document Work Plan (DWP) review cycles; retrieve/return archive records as required
• Embed Data Integrity principles within data management programs

Finance and Systems

• Execute SAP transactions related to manufacturing within defined timeframes and policy
• Provide SAP support to stakeholders; raise purchase requisitions for operating supplies
• Champion cost mitigation and reduction initiatives without compromising quality or safety

People and Collaboration

• Lead and contribute to Tier 1 meetings on a rotational basis; communicate clearly to diverse audiences
• Coach colleagues through competency-based training on indirect manufacturing activities
• Develop and deliver SAP training aligned to production roles and responsibilities

Environment, Health & Safety (EHS)

• Proactively identify hazards and near misses; support incident investigations and preventive actions
• Participate in safety audits and inspections, ensuring CAPAs are assigned and closed on time
• Partner with Management to meet EHS requirements and compile timely EHS reports for leadership and regulators

• Proven experience in a regulated and/or manufacturing environment
• Bachelor of Science (or equivalent qualifications/industry experience)
• Strong understanding of GMP, Quality Systems, aseptic processes, and GMP behaviors
• Proven SAP proficiency (including Master Data) and confident with Office 365 and data analytics tools
• Excellent communication, coaching, organization, and teamwork skills
• Demonstrated leadership: ability to train, motivate, and utilize teams in a multifaceted setting
• Strong problem-solving mindset with high attention to detail
• Solid grasp of EHS risk assessment, mitigation, and management processes

• High-impact role central to batch readiness, compliance, and operational flow
• Cross-functional exposure and visibility within Manufacturing and Quality
• Opportunity to lead training, drive continuous improvement, and shape site standards
• A culture that values safety, integrity, teamwork, and continuous learning

Required Skills:

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

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Hazardous Material(s):

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