Senior Process Commercialisation Engineer

Collins McNicholas Recruitment; Tipperary; On-site; EUR 90,000 - 130,000; Full time

Job summary

Collins McNicholas Recruitment is seeking an experienced Senior Process Commercialisation Engineer for a global pharmaceutical manufacturer. You will lead the introduction, transfer and optimisation of processes, ensuring successful development and scale-up into commercial manufacturing.

The role requires a chemical/process engineering degree and roughly 5+ years in regulated pharma environments, with strong technical problem solving, cross-functional collaboration and a proactive approach to

Qualifications

• 5+ years' experience in pharmaceutical manufacturing or process engineering.
• Experience with process development, scale-up, optimisation or technology transfer.
• Strong problem-solving and cross-functional collaboration.
• GMP/regulatory environment experience.

Responsibilities

• Lead transfer and development of API processes from development to manufacturing.
• Coordinate new product introductions and technical transfers with global teams.
• Oversight of process development, scale-up, validation and filing strategies.
• Guide site on new technologies and drive timely project delivery.

Skills

Problem solving

Communication

Project ownership

Stakeholder influence

Education

Chemical/Process Engineering degree

Job description

Are you an experienced Chemical or Process Engineer with a background in pharmaceutical manufacturing, process development or technology transfer? Would you like the opportunity to work on new product introductions, technical transfers and process optimisation within a global pharmaceutical organisation? This is an exciting opportunity for an experienced engineer to take a leading technical role in bringing new and improved pharmaceutical products into commercial manufacturing.

The Role (Full job description on request)

As a Senior Process Commercialisation Engineer, you will play a key role in supporting the introduction and optimisation of pharmaceutical products and processes. You’ll take ownership of technical projects, working with both local and global teams to ensure processes are successfully developed, transferred, scaled up and introduced into manufacturing.

• 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 productlaunchmilestones,thiswill 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,processmonitoringandtime cycle study, deviation investigations and resolution, and developing filing strategies.
• You will have an aptitude for technical problem solving, with a background in solving technical issues to obtain a positive outcome.
• Knowledge and SubjectmatterexpertiseonAPI processing unit operations and scale up opportunities are a core part of the role.
• Abilitytoidentifyandovercome constraints and tests to ensure successful demonstration of processes through piloting and validation.
• You will be expected to develop subjectmatterexpertiseinProcess orChemicalEngineeringinternally and Externally within the Pharmaceutical Industry.

What we’re looking for

• A degree in Chemical Engineering, Process Engineering or a related discipline.
• Approximately 5+ years' relevant experience within pharmaceutical manufacturing, process development, process engineering or a similar regulated manufacturing environment.
• Experience working with process development, scale-up, optimisation or technology transfer.
• Strong technical problem-solving skills and the ability to identify practical solutions to complex manufacturing challenges.
• You 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.
• Experience working within a GMP/regulatory environment.
• The ability to work effectively across multiple functions and influence stakeholders at different levels.
• Strong communication skills, with the confidence to lead technical discussions and bring people together around a common objective.
• A self‑motivated and proactive approach, with the ability to take ownership of projects and drive them forward.