CQV Engineer

Arcadis; Ireland; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading engineering firm in Ireland is seeking a CQV Engineer to support the on-site Commissioning, Qualification, and Validation (CQV) processes for a pharmaceutical company in Athlone. The role requires experience in GMP environments and proficiency in drafting CQV documentation. Candidates should possess strong organizational and communication skills, with the ability to work collaboratively in a dynamic environment. This is a unique opportunity to ensure compliance and support continuous improvement efforts.

Qualifications

• Experience in Commissioning, Qualification, and Validation processes within the pharmaceutical industry.
• Experience in GMP environments, particularly in drug product and packaging.
• Ability to work in fast-paced, dynamic environments and foster collaboration.

Responsibilities

• Support the on-site CQV process and ensure compliance with regulations.
• Draft and review CQV documentation like protocols and reports.
• Support installation and start-up of equipment in a compliant manner.

Skills

Pharmaceutical industry experience in CQV processes

Excellent organizational skills

Strong communication skills

Ability to work independently

Competence with MS Word/Excel/PowerPoint

Job description

Arcadis are seeking a CQV Engineer (utilities, vessels and packing) for on an onsite contract assignment with a leading pharmaceutical company in Athlone.

Brief Description:

• Ensure that systems and equipment are properly installed on the site, meet design specifications and are capable of producing high-quality product.
• This position may also support new process introduction and process qualification activities as required.
• The role may work in close collaboration with a project team lead who is the primary owner of the team processes, tools, metrics, and all aspects of project management to ensure successful completion of assigned projects.

Essential Functions/Responsibilities:

• Support the on-site Commissioning, Qualification and Validation (CQV) process. Draft, review, and approve CQV documentation (protocols, reports, change controls, deviations) as appropriate. Support re-qualification activities as required.
• Support the installation and start-up of equipment and systems in a safe compliant manner. Verify that all equipment functions safely and meets user requirements. Ensure systems and equipment that impact product quality and patient safety are correctly installed and fit for intended use.
• Assessment of site systems for compliance with new or developing regulatory expectations as they apply to validation.
• Generate documentary evidence that processes and systems consistently produce reproducible results in compliance with regulatory standards.
• Support process validation / qualification activities as required.
• Support and lead continuous improvement activities.
• Provide trouble shooting & technical input to significant issues/ deviations etc.
• Work with global functions and other sites to facilitate transfer of technical knowledge.
• Support the global regulatory team in dossier development or post market changes as required.
• Provide support as appropriate to New Product and Technology Introduction teams.
• Support manufacturing and site activities with technical support as required.

Required knowledge, skills and abilities

• Pharmaceutical industry experience in Commissioning, Qualification and Validation processes.
• Experience supporting manufacturing, process support, process validation and process troubleshooting in a GMP environment desirable.
• Experience in drug product and packaging environments preferential.
• Excellent organizational, verbal, communication, presentation, and data analysis skills.
• Ability to work independently, as well as a member of multi-disciplinary teams in a dynamic, fast-paced environment.
• Ability to establish collaborative working relationships at all levels, regardless of seniority.
• Strong understanding of project management processes, risk management processes, pharmaceutical quality management systems and pharmaceutical regulations.
• High level of competence with MS Word/Excel/Power point.
• Experience of project management on technical programs is desirable.