Job Description

A new position has arisen in our growing Commercialisation, Development and Supply (CDS) team for a Specialist, Engineering in new small molecule API Commercialisation. This role provides exciting and interesting opportunities to work on multiple API projects, ranging from manufacturing support activities to late-stage clinical product development and scale-up, new product introductions, supply campaigns and technology transfers across our existing and new facilities of the future.

What you will do:

Work as part of a multi-functional, diverse team to deliver results within schedule and product launch milestones. Bring energy, knowledge and passion about science and technology to carry out the following:

Collaborate closely with the Technical Team Leads to ensure the efficient operation of multiple small molecule processes. Individual contributor on new product introductions, supply and/or technical transfers to and from the site, including new technologies.

Collaborate with global Research and Development partners to co-develop new small molecule API products, supporting innovation from early development through to commercial readiness.

Provide support for process start-ups, production campaigns, and plant turnarounds to ensure safe, efficient, and compliant operations.

Development of batch documentation in compliance with cGMPs and EHS policies. Reviewing and approving paper & electronic batch records and automated recipes for various steps in the manufacturing process.

Support the evaluation and selection of raw materials, development of process fits and ensure alignment with regulatory and validation requirements. Contribute to the creation of robust filing strategies to support product execution.

Mentoring and supporting graduate and entry-level process engineers in managing their assigned processes during campaigns, ensuring adherence to yield, quality, and safety targets.

Lead investigations into process-related issues by identifying root causes and driving the implementation of effective corrective and preventive actions (CAPAs).

Proactively identify opportunities for equipment and process enhancements, and lead the implementation of improvements to optimize performance and reliability.

Providing technical representation for major projects and participating in the URS, IQ, DQ, OQ, and PQ phases as needed.

Partner with cross-functional teams—including Safety, Quality Assurance, Projects, and Process Chemistry—to support seamless production operations. Share expertise in API processing unit operations and scale-up with colleagues across Quality, Supply Chain, and Manufacturing to drive technical excellence and operational efficiency.

Communicating effectively with stakeholders at all levels of the organization, sharing technical expertise, and guiding complex projects.

What skills you will need:

To excel in this role, you will more than likely have:

A degree in Chemical Engineering or related discipline and a minimum of 2 years post-graduation experience in a pharmaceutical manufacturing organisation, or a PhD in Chemical Engineering or related discipline. Experience in API process development and/or API supply is a distinct advantage. 

Experience with process modeling, simulation, or data analytics is a strong asset.

Demonstrates self-motivation and a proactive approach to driving continuous improvement and inspiring team collaboration.

Exhibits high levels of personal integrity, credibility, and enthusiasm.

Proven ability to work effectively within diverse, cross-functional teams.

Strong analytical and problem-solving capabilities, with a track record of overcoming complex technical and chemical processing challenges.

Excellent communication skills, with the ability to engage constructively and compliantly across all levels of the organisation.

As a company, we are committed to ‘Inventing for Life’ in all that we do. 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. 

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

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.

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:

Chemical Engineering, Data Analysis, Engineering Design, Engineering Standards, Estimation and Planning, Industrial Engineering, Manufacturing Equipment, Manufacturing Scale-Up, Problem Solving, Process Improvements, Professional Engineering, Project Management, Self Motivation, Teamwork, Technical Writing

 Preferred Skills:

Job Posting End Date:

09/18/2025

*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.

Requisition ID:R364404