£30,000 - £40,000 / year
My Client, an International Drug and Medical Device Manufacturer, needs a Manufacturing Engineer to join their team for a 12-month fixed term contract. For this role, experience in a highly regulated environment, Medical, Aerospace, Automotive etc, and have plenty of proven experience problem solving, RCA as a natural and instinctive process, and corrective actions.
The salary would be £30-40k + Bonus, and usual benefits of working for an International Business.
You will be working in the Manufacturing Technical Support function, developing and providing technical expertise to support day to day manufacturing activities, proactively managing risk in the process, and delivering improvement projects to Pharmaceutical / Medical Device manufacturing processes.
1. Provide expert Technical/Manufacturing/Process engineering knowledge and investigation expertise for significant quality events in all areas of the manufacturing process. Facilitate multi-functional problem-solving teams to drive the identification of root cause, and corrective and preventative actions within required time scales.
2. Use technical expertise and influence to identify significant process improvement projects for medical device and drug device combination products, aligned to site strategy (safety, quality, cost, delivery and people). Project manage these through generation of data/technical justification, implementation and qualification, finally checking benefits have been achieved and identifying further potential for improvement.
3. Implementation of change controls for process or equipment changes within Manufacturing, acting as change control owner, co-ordinating the impact assessment, ensuring approvals are in place before implementation to maintain compliance, then following up so all actions are complete for closure. 4. Maintaining and proactive use of risk management documents, including Post Design Transfer Files, Critical Process Parameter documents and Process Failure Mode Effects Analysis (pFMEAs).
5. Carry out trending of data, proactively assessing the capability of the process, ensuring action is taken before product quality is impacted.
6. Investigate and provide technical input into customer complaints, including the generation of reports in liaison with the Quality Department. 7. Taking responsibility for validation of manufacturing processes, including agreeing scope with key stakeholders. Documenting and carrying out this validation to ensure the site processes are maintained in a validated and compliant state.
8. Lead and manage the process of technical transfers (including process development, scale up and new product introduction) from development to manufacturing and between sites/companies. Act as site project manager to ensure that actions are identified and tracked for compliance and delivery in line with agreed overall project plans and provide regular updates/feedback to key stakeholders to ensure visibility of project progress is maintained.
9. Ensure Quality and EHS compliance at all time.
10. Ensure all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished in accordance with the Client’s values.
Education and Experience required
1. Degree qualified (engineering / science related), or significant medical device and/or pharmaceutical industry experience supported by alternative qualifications
2. Minimum 5 years’ experience of Manufacturing or Product Development in the Pharmaceutical and/or Medical Device industry (some other highly regulated (Aerospace) and quality driven industries may be considered).
3. Preferably some knowledge of cGMP, ISO13485, 21CFR 820 and other relevant regulatory requirements.
4. Able to demonstrate application of continuous improvement tools and techniques (Root cause analysis, Fishbone Diagrams, six sigma, statistical analysis etc.) to deliver significant business benefit.
5. Project management experience/qualification would be advantageous
Skills and Attributes required
1. A dynamic and ambitious professional with proven delivery record.
2. Strong team player able to demonstrate ability to lead and facilitate informal and formal teams in the development and delivery of quality solutions.
3. Able to work across a matrixed organisational environment.
4. Must be able to work under pressure and co-ordinate multiple activities concurrently.
5. Hands on approach, problem solving mind set, good attention to detail, organised and methodical.
6. Demonstrated ability to extract critical information to enable effective and appropriate decision making.
7. Willing to learn and develop skills and knowledge.
8. A high level of written and spoken English