Job Description
An amazing opportunity has arisen for a Process Commercialisation Senior Engineer. The role will support internal and external manufacturing operations, remain operational, continuously improve and innovate.
What You Will Do
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, directing day‑to‑day development plans across projects and working closely with Research and Development partners globally.
This 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 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 core to the role, with the ability to identify and overcome constraints to ensure successful demonstration of processes through piloting and validation. The incumbent will 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, a proven record of imparting and guiding complex projects across boundaries, and the 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
A qualification in Chemical Engineering or a related discipline.
A minimum of 5 years post‑graduation experience 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.
Required Skills
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
Requisition ID: R389657
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