Job Description

A fantastic opportunity has arisen in the Integrated Process Teams (IPTs) focused on Downstream manufacturing. The Manufacturing Technical Excellence Lead (Mgr.) will act as a team lead and with a focus on a specific unit operation or compliance.

The successful candidate will develop, communicate, and execute a data-driven cross-enterprise schedule to ensure successful site delivery, achieving our Governance Pillars in People, Safety, Quality, Delivery, and Cost. This role is critical for managing the production schedule, planning changeovers, conducting audits, and optimizing plant operations to ensure effective and efficient production through driving a safety, compliance, and right-first-time mindset.

Our facility in Dunboyne is a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility supports seamless connection and collaboration within and across teams and functions. Our Dunboyne facility provides Biologics Drug Substance manufacturing for Clinical Supply, Registration, and Commercial Launch.

Responsibilities

• Lead, coach, and develop a high-performing technical team.
• Foster a culture of accountability, collaboration, inclusion, and continuous learning.
• Establish clear performance expectations aligned with site and departmental goals.
• Provide regular feedback, coaching, and mentoring to team members.
• Act as a role model for company values and leadership behaviours.
• Promote a strong safety culture and lead by example in EHS performance.
• Support/Lead and participate in safety audits, investigations, and risk assessments.
• Ensure compliance with site procedures, global policies, and regulatory requirements.
• Maintain a constant state of audit and inspection readiness.
• Drive timely completion of corrective and preventative actions (CAPAs).
• Provide technical oversight and support for manufacturing operations.
• Lead and facilitate complex investigations related to safety, quality, and operational performance.
• Utilize structured problem-solving methodologies to identify root causes and implement sustainable solutions.
• Support process monitoring and execution of performance improvement initiatives.
• Ensure technical issues impacting production are escalated, acting as an escalation point throughout manufacturing and ensuring resolution appropriately as per site escalation strategy.
• Provide technical assessment and support/lead deviations, change controls, and quality events.
• Drive continuous improvement initiatives using MPS and Operational Excellence tools.
• Support site productivity, capacity, and efficiency improvements.
• Monitor and trend operational performance metrics, identify opportunities to reduce waste, improve reliability, and increase process robustness.
• Support implementation of strategic site projects and business initiatives.
• Ensure manufacturing activities are executed in accordance with cGMP requirements.
• Review and approve GMP documentation as required.
• Support Quality Management System (QMS) activities.
• Ensure adherence to approved procedures, work instructions, and quality standards.
• Promote a culture of Right First-Time execution and data integrity.
• Act as a key interface between Manufacturing, Quality, Engineering, Automation, Supply Chain, Validation, and Technical Services.
• Support and lead project execution and change management activities.
• Communicate effectively with stakeholders to ensure alignment and successful execution of priorities.
• Support site governance and escalation processes.
• Role may require some shift work/ out-of-hour support for manufacturing activities.
• On-the-floor current Good Manufacturing Practice (cGMP) manufacturing and familiarity with regulatory requirements.
• Familiar with all Safety, GMP, Environmental and Validation permits, policies, and procedures.
• Familiar with plant equipment.
• Training others and/ or leading hands-on or instructor-led training.
• Ability to read, write and understand technical information.

Skills & Qualifications

• Minimum level 8 bachelor’s degree in engineering or science-based discipline or equivalent.
• A master’s is desirable.
• Proven leader capability in developing people and teams with at least 3 years’ experience leading teams to successful outcomes.
• Proven record of accomplishments of working for a minimum of 5 years in a Pharma/Biopharma company or related industry is desirable.
• Proven ability around working cross functionally, focusing on meeting, tracking schedules, and embracing an interdependent work culture.
• Experience working in a GMP/regulated environment is required.
• Proficiency with automated systems such as Manufacturing Execution System (MES), Systems Applications and Products (SAP), Delta V.
• Knowledge of Lean methodologies.

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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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. 

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