Aseptic Lead, Operations - Dundalk

Merck Gruppe - MSD Sharp & Dohme; Leinster; On-site; EUR 85,000 - 110,000; Full time

Job summary

Merck Sharp & Dohme seeks an experienced Aseptic expert to strengthen sterile manufacturing standards and build long‑term capability. The role shapes aseptic practices across the site, ensuring robust processes, qualified personnel, and contamination control to support ongoing success.

The position prepares the site for commercial sterile manufacturing, with a focus on achieving inspection readiness and aligning aseptic objectives with site goals.

Qualifications

• 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 GMP Audits experience preferred.

Responsibilities

• Lead 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 End-to-End Media fill program, including strategy and GMP Audit defense.
• Develop and grow the Isolator Glove Management Program at the site.
• Contribute to cleanroom operations and contamination control procedures.
• Ensure compliance with company policies, procedures, and regulatory requirements with cGMP in daily activities.
• Provide SME insight during deviations or audit activities and serve as the IPT lead in Sterile Council and Sterile CoP.

Skills

Adaptability

Aseptic Operations

Contamination Control

Decision Making

Process Improvements

Sterile Manufacturing

Training Program Management

Education

Bachelor’s Degree or higher in Science, Engineering, or related technical discipline

Job description

Job Description

Position Overview

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.

The role is instrumental in preparing the site for commercial sterile manufacturing by ensuring

robust aseptic processes, qualified personnel, effective contamination control measures, and

inspection‑ready systems that support long‑term operational success.

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.

Required Skills:

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

Preferred Skills:

Secondary Language(s) Job Description:

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.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Pleasedon’thesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office‑based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,

Search Firm Representatives Please Read Carefully

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:

08/31/2026

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:

R412014