Manufacturing Associate Specialist

Job Description

An amazing opportunity has arisen for a Manufacturing Associate Specialist at our Dundalk site. You will be responsible for providing day-to day operational support to the DS manufacturing teams, including hands-on support during campaigns and troubleshooting production/process issues.

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

• Own and coordinate document control activities: create, review, revise and archive SOPs, OJTs, risk assessments, quality statements. Ensure documents are compliant, controlled and accessible.  
• Attend, facilitate Tier and cross-functional meetings. Escalate issues promptly to maintain business continuity.  
• Drive continuous improvement: identify, propose and support implementation of process and documentation improvements to increase quality, reduce risk and accelerate production readiness.  
• Perform all duties in accordance with cGMP, SOPs, and controlled documents.

What skills you will need:

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

• Minimum BSc Degree in Science, Biotechnology.
• Experience in biopharmaceutical manufacturing. 
• Experience with GMP systems. 
• Ideally have a solid understanding of quality system in terms of deviation, investigation, CAPA and change control. 
• Able to coordinate cross-functional activities, lead meetings and escalate effectively to maintain business continuity.
• Excellent document writing, review and technical-communication skills; attention to detail for controlled documents and templates
• An enthusiastic individual who has demonstrated the ability to adapt to daily challenges of a manufacturing work environment while maintaining a positive and productive attitude and fostering this attitude among direct reports. 
• Create, review manufacturing documentation as needed.

Required Skills:

Accountability, Biopharmaceutical Industry, Biotechnology, Business Administration, Continual Improvement Process, Detail-Oriented, Document Controls, GMP Compliance, Manufacturing, Manufacturing Documentation, Manufacturing Support, Operations Management, Pharmaceutical Microbiology, Production Optimization, Quality Management

Preferred Skills:

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

12/15/2025

*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.