Validation Excellence: Author, execute, and lead process and cleaning validation programs to guarantee seamless compliance with cGMP, cleaning validation requirements, and global regulatory expectations.
Technical Support & Troubleshooting: Provide high-level scientific and technical troubleshooting support to the IPT for multiple active manufacturing processes, evaluating raw materials, and ensuring process robustness.
Project Management: Operate effectively as a project leader, using robust planning to identify needs, priorities, risks, and accountabilities to ensure successful outcomes for new product introductions and technology transfers.
Continuous Improvement: Pioneer the application and sharing of cutting-edge techniques and processes. Identify and implement improvements in processes and business systems, utilizing Lean Six Sigma (LSS) tools to drive efficiency and optimization.
Quality & Compliance: Ensure all engineering operations comply with cGMP, Environmental, and Health & Safety regulations. Act as a Sub-System Owner for various Quality Management System (QMS) areas, ensuring that all processes conform to site, divisional, and corporate quality standards.
Required Skills & Qualifications
BSc, BEng, or higher in Chemical Engineering, Chemistry, Natural Sciences, or a related discipline. An advanced degree (MSc, PhD) is beneficial.
A minimum of 6 years of post-graduation experience in a pharmaceutical process development, manufacturing, and technology transfer environment.
Strong, demonstrated understanding of process chemistry, formulation technology, and engineering principles specifically applied to solid oral dosage (OSD) platforms.
Expertise in process development, scale-up, technology transfer, and cleaning validation.
In-depth knowledge of cGMPs, global regulatory expectations, and Quality Risk Management (QRM).
Proven experience with deviation management systems, root-cause analysis (8-Step methodology), and production operations.
Excellent written and verbal communication, with a proven ability to present complex technical data to diverse audiences.
Demonstrated capability to lead project teams and work collaboratively across functional boundaries.
Strong project management, problem-solving, and time-management skills.
Ability to work in partnership with all plant departments, including PCT, process engineering, central engineering, and global manufacturing division groups.
Ballydine is the primary Drug Substance commercialisation hub within the network, where new processes are scaled and transitioned to commercial manufacture. The site supports clinical and commercial API supply and the transfer of processes and technologies across internal manufacturing sites and external partners.
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. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
Additional location(s) Compensation Information
Required Skills
Chemical Engineering, Continuous Improvement Techniques, Drug Product Development, Good Manufacturing Practices (GMP), New Product Introduction (NPI), Pharmaceutical Process Development, Project Management, Regulatory Compliance, Solid Dosage Forms, Technical Transfer
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
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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
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
- 11/18/2026
- 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.
