Senior Process Engineer
Senior Process Engineer
An exciting opportunity has arisen to for a Senior Process Engineer to join BPL, a niche pharmaceutical business based near to Watford at a time where it is embarking on a programme of investment in all areas of the business.
This position would provide the successful candidate an opportunity to work within an environment transforming established processes into industry best practise and to support the development of site process engineering procedures and policies for BPL going forward.
The main purpose of the role is to work alongside the Head of Process Engineering and to be involved in the following:
- Provide process engineering expertise for production of products in a pharmaceutical, GxP environment
- Provide hands-on troubleshooting of existing processes and equipment, determine root cause and ensure availability and yield requirements are met
- Identify areas to improve process robustness and provide pragmatic, sustainable solutions that meet best practice
- Lead and provide technical expertise on all aspects of process engineering including feasibility studies, concept and detailed design, constructability, commissioning and operation.
- Manage complex, cross-functional projects to ensure that the deliverables are aligned to business needs
- Provide technical support to resolve quality deviations and safety incidents using structured root cause analysis techniques.
- Provide process safety support/expertise (HAZOP, ATEX), ensuring that all processes and changes that are implemented result in a safe process.
- Champion GEP within the department and mentor less experienced team members.
Qualifications and Experience
* Degree Level Education preferably in Chemical Engineering or other related engineering discipline
* 7+ years' experience working in the Pharmaceutical industry, preferably in a sterile manufacturing environment with experience of protein and biochemical processing unit operations.
* Proven scale-up and technology transfer experience. Knowledge of chromatography, filtration (ultra/dia/viral), lyophilization and aseptic filling processes is desirable
* Strong understanding of Process Engineering fundamentals with practical experience of designing pharmaceutical processes and utility systems to cGMP and regulatory requirements.
* Knowledge in the application of safety standards (e.g. PED, pressure relief assessment)
* Experience in developing process engineering site standards, process reliability and capability programmes desired
* Experience with documentation and practices in a regulated environment (e.g. GxP, FDA, MHRA)
* Strong leadership skills
* Excellent communication skills in both verbal and written forms and ability to describe complex process engineering matters to technical and non-technical people
* Proven skills in working/leading interdisciplinary teams to deliver projects, troubleshoot technical issues and implement effective permanent solutions
* Demonstrated attention to detail and organisational skills needed to successfully execute multiple activities and prioritize work load.
* Be able to build effective internal and external relationships and influence individuals across a variety of functions without a direct reporting relationship.
* Self-motivated, with desire to take ownership of activities and work with minimal direction
* Change agent and a people person
* Committed team player with hands-on approach
* Comfortable with ambiguity, flexible and adaptable
* Perseverance to determine root cause and drive to deliver industry best practice solutions
* Willing to work off-hours and weekends as needed to accommodate critical production and validation schedules during shutdowns and perform functions in a cleanroom environment while fully gowned