Validation Engineer
- Midlands (Ireland)
- Contract
- Commissioning, Qualification and Validation
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for Validation Engineer to join their state of the art pharmaceutical facility.
Located in the historic province of Connacht neighbouring the pond that is the Atlantic Ocean, breeds a mix of Irish culture and modernisation in the popular seaside town rife with bars, restaurants and water sports.
Responsibilities:
- Ensure all Computerised systems are qualified in compliance with Data Integrity policies and regulatory requirements.
- Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
- Generation/maintenance of the Validation Master Plans.
- Generation/maintenance of Project Validation Plans.
- Generation of validation plans, protocols and final reports to cGMP standard.
- Review / approval of all protocols and final reports.
- Management of validation change control process.
- Adheres to and supports all EHS & E standards, procedures and policies
Requirements:
- 3rd level qualification in a relevant engineering or scientific discipline.
- A minimum of 5-10 years’ experience in a cGMP regulated environment.
- A good understanding of regulatory requirements.
- Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
- Requires proven problem-solving skills and the ability to adapt to new regulatory requirements.
- Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
- Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
If this role is of interest to you, please apply now!
#LI-JS4
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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