Process Engineer 6 month fixed term contract £30-40k pro rata

  • Farnham, Surrey
  • £30-40k pro rata
  • dh 25
  • 01267 610 902

Job Description

Process Engineer – 6 month fixed term contract – £30-40k pro rata
 
Our Client is a growing international specialist healthcare company. Their mission is to bring to market medical products that meet the needs of specialist healthcare physicians and their patients.
In this role, you would be working within manufacturing as part of the Manufacturing Technical Support function; provide technical expertise and process knowledge to the manufacturing and supply functions and deliver improvement projects, process validation and new product introductions, to increase the efficiency, effectiveness and success of Manufacturing and Supply Operations.

Principal Responsibilities

  1. Provide ongoing expert technical/ engineering support and investigation expertise for significant quality events in all areas of the manufacturing process. Lead identification of root cause and implementation of effective CAPAs; ensuring delivery is completed in a compliant and timely matter.
  2. Acting as subject matter expert to lead the delivery of short to medium term projects; to ensure availability of capacity and capability to meet commercial demand.
  3. Use technical expertise and influence to identify opportunities for process improvement projects and new equipment introductions. Complete implementation through generation of data/technical justification, implementation and qualification.
  4. Lead process validation activities, including the generation of process validation protocols and reports, for commercial products to ensure that processes are developed and maintained in a validated and compliant state.
  5. 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. Ensure that actions are tracked for compliance and delivery in line with agreed plans and provide regular updates/feedback to key stakeholders to ensure visibility of project progress is maintained.
  6. Ensure that 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.
  7. Complying with the Client’s health and safety requirements.
  8. Carry out other reasonable tasks as required by the Line Manager.

Principal Relationships

  1. Accountable to –  MTS Manager
  2. Production Team, Quality Team, Validation engineers, EHS, Innovation Scientists and Engineers

Education and Experience

Must:

  1. Educated to degree level in Mechanical/Chemical/Process Engineering, or with significant medical device and/or pharmaceutical industry experience supported by alternative qualifications.
  2. Experience of Manufacturing or Product Development in the Pharmaceutical and/or Medical Device industry (other highly regulated and quality driven industries may be considered).

Preferred:

  1. Lean Six Sigma Green Belt Accredited
  2. Knowledge of cGMP, ISO13485, 21CFR 820 and other relevant regulatory requirements.
  3. Project management experience/qualification (e.g. Prince2) would be advantageous.
  4. Demonstrated experience in delivering new equipment/processes into manufacturing, through sourcing, development, qualification to commercialisation.
  5. Demonstrated experience in existing process and equipment optimisation and validation.

Skills and Attributes

  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.

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