Senior BioProcess Associate - Fill Finish

Posted 39 minutes 51 seconds ago by MSD Malaysia

Permanent
Full Time
Other
Leinster, Ireland
Job Description

Job Description: We are looking for a Senior BioProcess Associate to join our Drug Product team at our state-of-the-art, fully integrated vaccine facility in Dundalk, Ireland. This is an exciting opportunity to be part of a fast-growing, dynamic team working with cutting-edge technology at the forefront of vaccine manufacturing.

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

  • Perform core production activities in the Drug Product facility, with a high level of autonomy and accountability.
  • Operate equipment for formulation, filling, lyophilization, capping, and inspection.
  • Serve as a subject matter expert (SME) in Drug Product for the team, providing guidance, technical support, and best-practice leadership.
  • Support commissioning, qualification, validation, and start-up activities for new equipment and processes.
  • Complete manufacturing tasks in line with SOPs and batch records, both paper and electronic.
  • Maintain a safe and cGMP-compliant work environment.
  • Troubleshoot routine issues and support deviation investigations through the Quality System.
  • Write, review, and revise SOPs, batch records, logbooks, training competencies, work instructions, and job aids.
  • Support Continuous Improvement initiatives using Lean/Six Sigma tools and Standard Work principles.
  • Provide updates during shift handovers and contribute to team KPI delivery, including Safety, Quality, Schedule Adherence, OEE, and training.
  • Mentor, train, and support the development of other team members in Drug Product operations, helping to build capability and consistency across the team.
  • Support Maintenance, Engineering, Quality, and other functions as needed.
Required Skills
  • Certificate, Diploma, Degree, Trade qualification in Science, Engineering, or equivalent.
  • 5 years' experience in a regulated environment, ideally within biopharmaceutical or Drug Product operations.
  • Demonstrated experience working as part of a team and recording information in real time using electronic or manual systems.
  • Experience following SOPs, batch records, and manufacturing control systems.
  • Strong communication, attention to detail, documentation, and problem-solving skills.
  • Ability to work independently and as part of a self-managed shift team in a fast-paced environment.
  • Proven experience mentoring, coaching, and training others, with the ability to share knowledge effectively and support team development.
  • Strong technical understanding of Drug Product operations and the ability to act as a go-to resource for the team.
Preferred
  • Experience in the biopharmaceutical industry.
  • Experience working in Grade B, C, D, and CNC environments.
  • Experience in Drug Product operations.
  • Experience in start-up operations.
  • Experience in a fast-paced environment.

As a cutting-edge, state-of-the-art vaccines facility spanning over 15,500 square metres across three stories, our Dundalk site will focus on qualification, continued product development and expanding its capabilities within our network.Featuring drug substance manufacturing, drug product manufacturing and quality control labsthat 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.

Our Companies in Ireland is one of the country's leading healthcare companies, having first established here 50 years ago. The company has a dynamic and inclusive team of over 4,000 employees currently working across eight locations in Ballydine, Co. Tipperary, Brinny, Co. Cork, Dunboyne, Co. Meath, Dundalk, Co. Louth, Carlow and Dublin, and, in addition, operate substantial Human Health and Animal Health businesses. We work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network.

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

Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s):

Job Posting End Date: 08/26/2026 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.