Job Description

A new and exciting opportunity now exists on our Carlow Site for an Aseptic Lead / Specialist Operations within Manuf./Operations on the Carlow site.

What you will do:

Bring energy, knowledge, innovation to carry out the following:

• Assess the maturity of the teams aseptic and clean room ability
• Serve as site lead in Sterile Council and Sterile CoP and provide input to network sterile standards and guidelines.
• Assess team member training/development needs and ensure all receive appropriate training, resources and programs to develop technical and other skills to effectively complete their jobs.
• Develop and maintain training programs.
• Assist the team with development of objectives and ensures alignment with site goals.
• Foster an environment that allows for progressive, continuous improvement of skills and honest, open feedback focused on how/why to complete aseptic manufacturing process.
• Provide ongoing formal and informal feedback on the Aseptic qualification of the IPT operations team.
• Oversee coordination of resources to implement suggestions/ideas of merit within the clean room areas.
• Effectively lead the media fill (Process Simulation) development and execution.
• Responsible for contributing to the Cleanroom Operation and contamination control procedures in IPT including but not limited to: Cleaning and Sanitisation, Garbing, People, Material and Process Flow, and Segregation Procedures.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• Responsible for the coaching, mentoring and training of the operations teams on
  primary aseptic manufacturing, clean room management and behaviours within
  Carlow Site.
• Provide leadership, cross-functional development and technical expertise to operations team on the aseptic manufacture of biologics and vaccines at Carlow.
• Ensure that objectives are effectively achieved, consistent with company’s requirements to ensure compliance, safety and reliable supply to our customers.

What skills you will need:

In order to excel in this role, you will more than likely have:

• 5 years operations experience in a sterile manufacturing environment
• Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other technical discipline

At our company, we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. We’re always looking to make a difference for people, patients, and communities – from Ireland to the world.

Our Commitment to Ireland:

Our Company Ireland is one of the Ireland’s leading healthcare companies, having first established here over 50 years ago. We have a dynamic and diverse team of over 3,000 employees currently working across seven sites in Ballydine, Co Tipperary, Brinny, Co Cork, Dunboyne, Co Meath, Carlow, and Dublin, where, in addition, operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations, our Irish sites manufacture many of the company’s top products, helping save and enhance lives in over 140 countries around the world.

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.

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. Please don't hesitate 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, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Biological Manufacturing, cGMP Compliance, Clean Room Environment, Coaching, Column Chromatography, Communication, Computer Literacy, Contamination Control, Data Analysis, Environmental Health and Safety (EHS) Management, Equipment Set Up, Good Manufacturing Practices (GMP), Leadership, Lean Manufacturing Tools, Management Process, Pharmaceutical Manufacturing, Pharmaceutical Microbiology, Process Monitoring, Process Optimization, Process Simulation, Process Troubleshooting, Regulatory Compliance, Regulatory Requirements {+ 4 more}

Preferred Skills:

Job Posting End Date:

06/7/2025

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