Validation Analyst

Job Overview

Based within the QA Validation Department, the successful candidate will be involved in a range of Qualification/Validation activities, including validation of sterilisation and depyrogenation processes and validation of aseptic manufacturing and filling procedures. The successful candidate will join a well-established team of analysts and will have involvement in a range of validation activities across each of the Norbrook sites. As a member of the Validation Team, full training will be provided with regular one to one coaching and support, to facilitate your training and professional development.

Main Activities/Tasks

• Execution of Qualification activities in accordance with relevant protocols and standard operating procedures
• Execute thermal validation on autoclaves, depyrogenation tunnels and fixed tanks and pipework using thermocouple base data acquisition systems.
• Completion of the relevant laboratory activities associated with the validation trials.
• Participation in Media Fill Simulation Trials
• Interpretation and evaluation of acquired data and preparation of all documentation associated with the above including Validation Protocols, Validation Reports, Validation Master Plan and SOPs.
• Any other duties as deemed necessary by management.
• Through on-site training and mentoring the candidate will gain a good understanding of the use of thermal mapping to demonstrate process sterility.

Essential Criteria:

• Applicants should be able to demonstrate good working knowledge of current Good Manufacturing Practices (cGMP).
• Third level qualification in a science related discipline or a minimum of 12 months relevant industry experience in a Production, or laboratory setting and A-level(s) in a science related subject.
• Excellent written and oral communication skills as demonstrated in the application form and at interview.
• Have a ‘Hands On’ approach to working within a fast paced work environment.
• Proven ability to organise, plan and prioritize multiple concurrent tasks whilst maintaining a high level of accuracy in all work produced along with a proven ability to meet deadlines.

Desirable Criteria

• Knowledge of Pharmaceutical product manufacturing and filling processes.
• Experience in equipment / facility qualification in a GMP environment.
• Be familiar with the concept of the use of a biological challenge and thermal mapping to demonstrate process sterility.
• An understanding of the minimum requirements for sterilisation validation.
• Laboratory experience as part of studies.
• Experience of cleanroom operation.

Duration: Fixed Term Contract (9 months)

Location: Newry

Additional Information:

• Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
• We regret that applications received after the closing date/time will not be accepted.
• We are unable to sponsor/take over sponsorship of a Visa at this time.
• This role is based on a site that produces penicillin and as such, would not be suitable for those with a penicillin allergy.

Norbook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.