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Search Results for Validation Manager
Validation ManagerValidation Manager Our client a global pharmaceutical company based in Dublin is currently recruiting for a Validation Manager to join their team on a permanent basis. The Validation Manager will manage and coordinate the activities of the Technical services team which is made up of a Validation Specialist group and a Development lab group. Responsibilities • Formulate and plan development studies to support new product introduction, continuous improvement and company research objectives • Carry out validation activities as outlined in the Site Validation Policy a...
Principal Validation EngineerOur client, a Global Biopharmaceutical organisation based in South Dublin require a Principal Validation Engineer to join their growing team. The successful candidate will be required to be a Subject Matter Expert in their area of process responsibility. Responsibilities: •Be the site process owner for sterilisation, depyrogenation and Media Fills for Vials and syringes •Development of Validation Plans, Process Qualifications (PQs), and Process Simulations (Media Fills) for Vial and Syringe Filling. •Leading the team in Audit Preparation to en...
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Validation Manager Career Profile
Validation ManagerThe Validation Manager is responsible for the Validation and coordination of operation of machinery and process within the plant. This may be IT systems, various pieces of machinery or Cleaning processes. Salaries start at ca.€32,000 for an entry level position, with an experience Validation Manager being able to command €80,000+. Again, it's an area where many consult on short term contracts, when there is lots of project and construction work in the market.
Key Responsibilities of the Validation Manager
- To manage all operational validation activities within the client's organisation.
- To continue to develop and implement a compliant validation strategy for our client.
- To continue to develop and implement an efficient compliant and cost effective calibration and maintenance programme.
- To work closely with all departments and the Quality Department to ensure the operation of a validated environment according to GMP and other regulatory requirements
- Be capable of delivering high level reporting to the client's directors.
- Manage the process for the creation of documentation and requirements to include but not limited to the following:
- Computer Systems Validation Plans
- Equipment Validation Plans
- Cleaning Validation Plans
- Utility/Facility Validation Plans
- Components Area Validation Plans
- Tissue Business Master Validation Plan
- Despatch Validation Plans
- Environmental Monitoring Validation Plans
- Quality Control Validation Plans
- Scheduling, Planning and review of validation activities.
- Manage all facets of assigned validation projects while maintaining strong communication with client representative on project status and assistance needed.
Skills & Qualifications:
- Third level degree in a science/engineering/computer subject as a minimum.
- At least 5 years experience Validation Management experience ideally within the clinical, medical, laboratory or pharmaceutical industry.
- Good understanding and application of GMP and regulatory requirements.
- Experience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plans.
- Excellent communication / interpersonal skills
- Previously have managed or supervised a team of experienced engineers in a similar industry.
- Be a motivator and leader for such a team.
- Attention to detail.