Senior Commercialization Engineer

MSD Malaysia; Ireland; On-site; EUR 90,000 - 120,000; Full time

Job summary

MSD Malaysia is seeking a Process Commercialisation Senior Engineer to drive new product introductions and technology transfers within a global biopharmaceutical setting. You will lead cross-functional teams in process development and scale-up to ensure manufacturing readiness and regulatory compliance.

The role emphasizes problem solving, process optimization and collaboration with R&D partners to deliver robust manufacturing processes and filings.

Qualifications

• A qualification in Chemical Engineering or related discipline.
• Minimum 5 years post-graduation experience in pharmaceutical API manufacturing or process development.
• Strong problem-solving and analytical abilities.

Responsibilities

• Lead new product introductions and technical transfers to/from the site.
• Direct multi-functional teams to deliver projects on schedule and meet launch milestones.
• Oversee process evaluation, optimization, and validation activities for API processes.
• Ensure regulatory and safety/compliance standards are upheld across campaigns.

Skills

Chemical engineering knowledge

Problem solving

Team leadership

Regulatory compliance

Cross-functional collaboration

Education

Chemical Engineering qualification

Job description

Job Description

An amazing opportunity has arisen for a Process Commercialisation Senior Engineer. The role will support internal and external manufacturing operations remaining operational, continuously improve and innovate.

What you will do

Bring energy, knowledge, innovation and leadership to carry out the following: As a Senior Process Commercialisation Engineer in the Process Development and Commercialisation Department, your responsibilities will be: A key contributor and guiding the site on a new product introduction or technical transfer to and from the site, including new technologies. You will work as part of a multi-functional, diverse team to deliver results within schedule and product launch milestones, this will involve directing day to day will development plans across projects and working closely with Research and Development partners globally.

This direction involves evaluation of raw materials, development of process fits, optimisation and development of the chemical API process, participation in campaign preparation, safety and environmental reviews, batch sheet reviews, regulatory and validation compliance, process monitoring and time cycle study, deviation investigations and resolution, and developing filing strategies.

The successful candidate will have an aptitude for technical problem solving, with a background in solving technical issues to obtain a positive outcome.

Knowledge and Subject matter expertise on API processing unit operations and scale up opportunities are a core part of the role, with the ability to identify and overcome constraints and tests to ensure successful demonstration of processes through piloting and validation.

The incumbent would be expected to develop subject matter expertise in Process or Chemical Engineering internally within our company and Externally within the Pharmaceutical Industry.

The candidate will have excellent communication skills, with a proven record of imparting and guiding Complex projects across boundaries and an ability to convey and link with people at all levels of the organisation in a helpful, compliant manner.

Key attributes

Dedicated, unswerving, approachable and reliable.

What skills you will need

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

• A qualification in Chemical Engineering or related discipline.
• A minimum of 5 years post-graduation knowledge in a pharmaceutical API manufacturing or Process development role.
• Demonstrated ability to be self-motivated and focus others with respect to implementing identified improvement initiatives.
• High personal integrity, credibility and energy.
• Demonstrated ability to work as part of diverse teams in an all-encompassing manner.

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,

Who we are …

We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

Inspiring Your Career Growth. INVENT. IMPACT. INSPIRE.

Required Skills

• Adaptability, Adaptability, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, Change Control Processes, Chemical Engineering, Customer-Oriented, Deviation Investigations, Deviation Management, Engineering Standards, Environmental Health And Safety, Environmental Research, Good Manufacturing Practices (GMP), Immunotherapy, Maintenance Engineering, Manufacturing Process Validation, New Product Development, Oncology, Process Monitoring, Process Optimization, Regulatory Compliance, Root Cause Analysis (RCA), Self Motivation, Strategic Thinking {+ 2 more}

Search Firm Representatives 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: 09/1/2026

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.