Senior Process Development Engineer
You will be a key contributor and site lead of 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 support and direction involve 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 analysis, deviation investigations and resolution, and developing filing strategies.
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
- Lead engineer on new product introductions and/or technical transfers to and from the site, including new technologies.
- Co-develop new SM API products with Research and Development partners globally.
- Direct day-to-day project development plans.
- Provide knowledge and subject matter expertise on API processing unit operations and scale up to colleagues in Quality, Supply Chain and Manufacturing Operations.
- Evaluation of raw materials, development of process fits, safety and environmental reviews, batch sheet reviews, regulatory and validation compliance, process monitoring and cycle-time studies, deviation investigations and resolution, and development of filing strategies.
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. An advanced degree (MSc, PhD) in Scientific or Engineering related field is desirable.
- A minimum of 6 years post-graduation experience in a pharmaceutical manufacturing organisation or process development role with experience of new product introduction, technology transfer and process fit is an advantage.
- Experience in process modelling/simulation and/or data analytics would also be an preferred
- Experienced in leading cross-functional teams.
- Demonstrated ability to work as part of diverse teams in an all-encompassing manner.
- Key attributes: Dedicated, unswerving, approachable and reliable.