The Role:
* Responsible for implementation of process and machine solutions, provision of process/project engineering support to all stages of projects from initial definition through to performance analysis, project management as required, and project execution either as team leader or
team member.
* Provide technical specialisation in the core processes used and utilise this expertise to lead problem solving teams to address complex issues using the best industry practices and provide the most cost effective solutions.
* Expected to understand key process parameters and be able to understand the relationship between the process parameters and the product key characteristics to drive improvements.
* Supervise and manage outside contractors as necessary to complete project work.
* Responsible for implementation of small to medium size projects involving equipment and process modifications to support introduction of new products and changes to existing products.
* Ensure scale up Laboratory pilot large scale manufacturing in compliance with quality safety, costs and customer requirements.
* Responsible for completion of action items as assigned from safety audits, observations, or other investigations.
* Demonstrate best in class safety behaviors and ensure all work conforms to statutory & safety requirements, that all work is controlled by a suitable safe system of work (e.g. Permit to Work system) and take responsibility for ensuring all work meets required cGMP regulatory standards (e.g. FDA, MHRA).
Skills and experiences:
* Must have a minimum 5 years process/project engineering experience with proven track record of relevant process industry design experience and project completions.
* Demonstrated leadership of other people or other multi-functional groups.
* The Process/Project Engineer must possess excellent organizational skills in the areas of project management, time management, and work prioritization. The Process/Project Engineer is expected to assist the manufacturing and plant management with work prioritization through recommendations of process improvement needs.
* Must have excellent problem solving skills utilizing statistical and analytical methods to assist the manufacturing team with process optimization, improving capability and upgrades as needed to support new products.
* Must possess excellent leadership skills including good written and verbal communication skills, self-motivation, conflict resolution skills and team building skills in order to work and lead within the manufacturing team.
* Must possess excellent organizational skills in the areas of project management, time management, and work prioritization.
* Experience working within the pharmaceutical sector at API/ intermediates level. * Good understanding and working knowledge of cGMP within the current regulatory framework such as FDA, MHRA * Previous working experience with preparation and execution of qualification/ validation activities within a pharmaceutical or similar regulated setting.
Essential Skills / Qualifications:
* Bachelors degree in a relevant engineering discipline e.g. Chemical
* Masters degree in Chemical Process or Pharmaceutical Engineering.
* Chartered Engineer status (or equivalent) or working towards accreditation.
* Bias for Action and Achieving Results
* Strong problem solving and analytical skills
* Excellent planning and organizational skills
* Confident, clear and effective communicator
* Project management/ cost control
* Change Leadership
* Influence other
Desirable Skills / Qualifications:
* Six Sigma Green Belt, preferably Black Belt
* Significant Lean manufacturing training
* Continuous Improvement training
* Project management
* Proficient in CAD drawing
* HAZOP, Process safety (RC1, thermal stability)
About Fircroft:
Fircroft has been placing people in specialist technical industries for over 50 years, focusing on mid to senior level engineers for contract and permanent roles worldwide. By applying for this job you give consent for Fircroft to contact you, via email & telephone, to discuss your application along with future positions and Fircroft's services.
Fircroft is registered as a Data Controller with the Information Commissioner as required under the General Data Protection Regulation 2016/679. Fircroft will only process your personal data for the specific purposes of managing your application.