In this role you will report to the Mechanical Supervisor and be responsible for engineering maintenance activities to ensure our 24/7 manufacturing facility runs on schedule and to the defined standards. You will also support small engineering projects and larger capital investments within a highly regulated and controlled cGMP environment. Since we operate in a 24/7 production environment, the role will also entail the provision of out of hours support.
Key responsibilities include:
- Deputize engineering trades
- Ensuring maintenance activities are carried out in a safe, compliant and timely manner within the established KPI framework
- Project management of small engineering projects
- To contribute and provide support as required for large capital investment projects
- Provision of routine out-of-hours emergency call-out support on the engineering call-out rota
- To liaise with and take responsibility for on-site external engineering contractors/consultants to ensure all activities are conducted in line with agreed procedures and protocols
- Assisting with the planning and coordination of the annual shutdown plan, including the writing and reviewing of routine documentation such as SOPs, risk assessments, method statements and change requests
- Ensuring that all documentation is kept up to date and reflects correct validated status
- Provide non-routine support to engineering where appropriate
Qualifications and Experience
- Ideally having served a recognised mechanical engineering apprenticeship complete with supporting qualifications
- Candidates should have a minimum of 5 years’ post-apprenticeship experience within a process-oriented industrial environment
- Welding and fabricating skills are highly desirable but not compulsory
- Knowledge or previous experience of cGMP compliance, deviation management, change control, process improvement programmes is desirable
- Self-motivated, able to work without supervision
- Team player with good communication skills
- Good attention to detail especially in written work
The candidate will be challenged with the responsibility of multi-tasking, diverse workloads, and balancing daily priorities in line with the dynamic demands of routine manufacture and intense shutdown periods. Working in a highly regulated and controlled environment adds additional cGMP, GDP and GEP challenges.
Albumedix helps biopharmaceutical companies improve patient outcomes with a range of albumin-based products and technologies that facilitate the development of superior biotherapeutics.
Albumedix develops albumin-based products and technologies for advanced drug and vaccine formulation, extended drug half-life and improved drug delivery. Our products and technologies are used in clinical and marketed drugs and out-licensed to pharmaceutical and biotech companies worldwide. With over 25 years’ experience in the biopharmaceutical industry, we have the scientific, technical and regulatory expertise needed to support companies in moving faster to market with superior biotherapeutics. We also use this expertise to strengthen our own drug pipeline.
Submit your application to: firstname.lastname@example.org
Deadline for applications: January 11th, 2019