J3526HertfordshireEngineering Permanent£30,000 to £45,000 per annumFull Time06/02/2017Engineering
Engineering – Validation
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An exciting opportunity has opened up for a Validation Specialist to join a leading Biopharmaceutical company based in the Hertfordshire area. As the Validation Specialist you will be responsible for day-to-day operation of the Validation Compliance Unit to perform qualifications as directed by the Validation Manager. You will also deliver and support on the training for other members of the Validation team.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Validation Specialist will be varied however the key duties and responsibilities are as follows:
1. As Validation Specialist, you will ensure that the routine qualification and requalification activities, of defined critical items of manufacturing equipment, are planned and carried out to meet production schedule requirements.
2. You will generate and execute detailed and complex Validation Documentation including Installation Qualification, Operational Qualification, Performance Qualification, Validation Plans and Reports.
3. As Validation Specialist, you will take responsibility for the co-ordination and planning of a defined area of work as well as supervising other members of staff in areas which you have expertise.
4. You will liaise and co-operate with other departments to carry out Validation activities and changes necessary to meet cGMP and regulatory requirements.
To be successful in your application to this exciting opportunity as the Validation Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific or Engineering discipline or equivalent qualification and extensive experience within a highly regulated Pharmaceutical or Biopharmaceutical environment.
2. Proven industry experience in writing and executing equipment Validation documentation within a Pharmaceutical or Biopharmaceutical environment. Experience in other Validation areas is desirable.
3. A working knowledge of GMP and the regulatory requirements for Validation within the Pharmaceutical or Biopharmaceutical industry is essential.
Key Words: Validation | Engineer | Facility | Equipment | Utility | CSV | Process | Packaging | GMP | IQ | OQ | PQ | Biopharmaceutical | Pharmaceutical
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.