Qualification Engineer

CareerWise Recruitment; Waterford; On-site; EUR 50,000 - 70,000; Full time

Job summary

A recruitment agency is seeking a Qualification Engineer for a Waterford-based pharmaceutical client. The role involves designing and executing qualification programs, ensuring compliance with regulatory standards, and supporting validation processes. Ideal candidates should have a relevant degree and 3-5 years of experience in healthcare manufacturing, preferably in pharmaceuticals. The position is hybrid with 3 days on-site work required and is contracted for 12 months. Benefits include flexible working options.

Benefits

Work From Home

Qualifications

• 3-5 years’ experience in a healthcare manufacturing environment, ideally in pharmaceuticals.
• Capable of troubleshooting validation issues associated with projects and process development.
• Knowledge of requirements for GAMP, ISPE Baseline guides.
• Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA, and ISO guidelines.

Responsibilities

• Design and execute periodic qualification program.
• Report on periodic requalification studies for equipment, systems, and processes.
• Ensure compliance with cGMP and regulatory inspections.

Skills

Qualification Engineer

Validation Engineer

Education

Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec

Job description

A Qualification Engineer is required by CareerWise Recruitment for our Waterford based Pharmaceutical client. You will be required to support the site requalification program. The Periodic Qualification Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes . This is a 12 month contracting position. This is a hybrid position with 3 days on site required for the position

THE ROLE:

• Designing, executing and reporting on periodic qualification program.
• Designing, executing and reporting on periodic requalification studies for equipment, systems and processes.
• Ensuring periodic qualification studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.).
• Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation.
• Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times.
• Participation in external regulatory inspections.
• Support Site Change Control process.

REQUIREMENTS:

• Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)
• Experience: 3-5 years’ experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
• Capable of troubleshooting validation issues associated with projects, process development etc.
• Competent technical knowledge of pharmaceutical plants.
• Previous validation/product development experience would be highly advantageous for the role.
• Knowledge of requirements for of GAMP, ISPE Baseline guides.
• Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.

Please call Louise Mulligan today for further information or email:

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent

Skills:

Qualification Engineer, validation Engineer

Benefits:

Work From Home