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Search Results for Validation Manager
Job Title. Location Salary Actions

Associate Director Site Data Integrity Lead

Associate Director Site Data Integrity Lead Our client, a global biopharmaceutical manufacturer are currently recruiting an experienced Associate Director Site Data Integrity Lead to join their team on a permanent basis. Responsibilities: Oversee quality governance for electronic and computerized systems (e.g., MES, DeltaV, LIMS, ELN, SAP) Lead implementation of data integrity and computer system validation (CSV) processes Manage validation lifecycle, change control, deviations, and CAPAs Support regulatory inspections and maintain inspection re...

Location: Limerick,
Associate Director Site Data Integrity Lead 		Limerick Not Disclosed

Principal Engineer

Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. Role: Principal Device Equipment Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Benefits: Competitive salary, bonus, pension and full family healthcare Overview: The Princip...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Principal Engineer 		EU Not Disclosed

Principal Engineer

Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. Role: Principal Device Equipment Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Benefits: Competitive salary, bonus, pension and full family healthcare Overview: The Princip...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Principal Engineer 		EU Not Disclosed

Principal Engineer

Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. Role: Principal Device Equipment Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Benefits: Competitive salary, bonus, pension and full family healthcare Overview: The Princip...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Principal Engineer 		EU Not Disclosed

Principal Device Engineer

Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. Role: Principal Device Equipment Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Benefits: Competitive salary, bonus, pension and full family healthcare Overview: The Princip...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Principal Device Engineer 		EU Not Disclosed

Senior Equipment Design Engineer

Role: Senior Equipment Design Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Benefits: Competitive salary, bonus, pension and full family healthcare Overview: The Senior Device Equipment Engineer will be an SME in the management and delivery of equipment, inclusive of specification, procurement, delivery, qualification, and project management of the same. You will lead equipment delivery projects with the suppliers, inclusive of budget management, and ownership for specification and qu...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Equipment Design Engineer 		EU Not Disclosed

Technical Life Cycle & Engineering Manager

Job title: Technical Life Cycle & Engineering Manager Location: Ballybrit, Galway – Hybrid working model Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. About the role: The role leads a multi-functional team in the development and production of medical devices used for the treatment of stroke. This position works as a recognized manufacturing and process technical authority who can provide process engineering knowledge and oversight. The Technical Lif...

Location: Galway, Galway City,
Technical Life Cycle & Engineering Manager 		Galway Not Disclosed

Senior Equipment Design Engineer

Role: Senior Equipment Design Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17 Benefits: Competitive salary, bonus, pension and full family healthcare Overview: The Senior Device Equipment Engineer will be an SME in the management and delivery of equipment, inclusive of specification, procurement, delivery, qualification, and project management of the same. You will lead equipment delivery projects with the suppliers, inclusive of budget management, and ownership for specification and qu...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Equipment Design Engineer 		EU Not Disclosed

Senior Equipment Engineer

Company: My client are a Pharma and Medical Device company developing combination products who have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment Role: Senior Equipment Design Engineer Location: Newenham Court, Northern Cross, Malahide rd, Dub...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Senior Equipment Engineer 		EU Not Disclosed

Quality Manager - NPI

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Manager - NPI 		EU Not Disclosed

Technical Life Cycle & Engineering Manager

Job title: Technical Life Cycle & Engineering Manager Location: Ballybrit, Galway – Hybrid working model Benefits: Excellent salary, bonus, pension, healthcare and opportunity to grow your career with hugely exciting Medical Device organisation. About the role: The role leads a multi-functional team in the development and production of medical devices used for the treatment of stroke. This position works as a recognized manufacturing and process technical authority who can provide process engineering knowledge and oversight. The Technical Lif...

Location: Galway, Galway City,
Technical Life Cycle & Engineering Manager 		Galway Not Disclosed

Quality Manager

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution Company: My client have leveraged deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. They offer an excellent opportunity for anyone looking to grow their career in the Medical Device industry. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adher...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North,
Quality Manager 		EU Not Disclosed
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Validation Manager Career Profile

Validation Manager

The 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.