Aseptic Lead, Operations - Dundalk

Job Description

We’re looking for an experienced Aseptic expert who enjoys working hands‑on with teams to strengthen sterile manufacturing standards and build long‑term capability. You’ll be a trusted subject matter expert, shaping how aseptic practices are applied, improved, and sustained across the site.

Responsibilities

• Lead the Environmental and Media Simulation Programs within the manufacturing area.
• Develop and implement the Aseptic qualification process within the department.
• Oversee compliance enhancement projects in clean room areas.
• Manage the End-to-End Media fill program, including strategy, competency building, execution, and GMP Audit defense.
• Develop and grow the Isolator Glove Management Program at the site.
• Contribute to cleanroom operations and contamination control procedures, including cleaning, sanitization, garbing, and segregation.
• Ensure compliance with our company’s global policies, procedures, guidelines, and regulatory requirements, executing cGMP in daily activities.
• Provide SME insight during deviations or audit activities and serve as the manufacturing IPT lead in Sterile Council and Sterile CoP.

Qualifications

Required

• Bachelor’s Degree or higher in Science, Engineering, or related technical discipline.
• Minimum of 5 years’ experience in Drug Product and sterile manufacturing operations.
• Experience with Media Simulations, either executing or coaching teams.
• Knowledge of sterile filling processes and equipment, particularly Grade A Isolator.
• Prior experience with GMP Audits.

Preferred

• Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and external customers in a team-oriented manner.
• Excellent planning and organization skills to manage training programs, assessments, and cleanroom support.
• Ability to align Aseptic team objectives with wider site goals and sterility assurance priorities.

Our cutting-edge, state-of-the-art vaccines facility in Dundalk site focuses on qualification, continued product development and expanding its capabilities within our network. Featuring drug substance manufacturing, drug product manufacturing and quality control labs that will support the global supply of vaccine products - strengthening our ability to make an impact on people and patients worldwide by adding new capabilities to our already industry-leading network.

Required Skills:

Adaptability, Aseptic Operations, Contamination Control, Decision Making, Process Improvements, Process Simulation, Sterile Manufacturing, Training Program Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

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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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/8/2026

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