Overview
PM Group's (Outsourced Technical Services) OTS department are seeking to recruit a CQV Engineer to be based on our client's site in Co. Wicklow.
We are looking for Intermediate to Senior Engineers who will bring their expertise with them and drive a number of Capex projects to completion.
Responsibilities
Duties:
* Performs commissioning, qualification, and validation testing on utilities and manufacturing process equipment and instruments under the Sr CQV Specialist's, CQV Engineer II’s or Senior CQV Engineer’s direct or indirect supervision.
* Authors protocols.
* Initiates controlled documentation in support of CQV projects as part of a team.
* Develops documents such as master plans, design qualification, equipment, facility and utility commissioning and final reports under the Sr CQV Specialist's, CQV Engineer II's or Senior CQV Engineer's direct or indirect supervision.
* Interacts with clients to identify CQV needs and work toward solutions that meet schedule, cost, and quality expectations and requirements based on Good Engineering Practices under direct or indirect supervision from the Senior Management.
* Follows project planning, management and execution schedules.
* Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use.
* Investigates failures and deviations; creates reports.
* Analyses and reviews spare parts lists to ensure they are fit for purpose.
* Reviews engineering drawings for accuracy and acts to correct errors under direct or indirect supervision of the CQV Engineer or Sr. CQV Engineer.
* Performs system walk-downs and makes changes using the change control of processes.
* Assists with Corrective and Preventative Actions (CAPAs) and makes recommendations to resolve deficiencies under supervision of the Sr CQV Specialist, CQV Engineer II or Sr CQV Engineer.
* Creates summary and analyses reports.
* Creates and maintains job plans, maintenance schedules and PMs under direct or indirect supervision of the Sr. CQV Specialist, CQV Engineer II or Sr. CQV Engineer.
* Understands scope change and identifies scope change to supervisors for resolution.
Qualifications
Qualification:
* Clear understanding of cGMPs and pharmaceutical operations.
* Understands and is able to apply principles of commissioning and qualification.
* Good analytical, organizational, time management and problem-solving skills.
* Good writing skills. Able to develop and execute DQ, FAT, SAT, OQ, PQ, develop SOPs, create final reports and author validation and quality policies, procedures and guidelines under direct or indirect supervision of the Senior engineering team.
* Basic understanding of working in a construction environment and possess basic understanding and knowledge to apply current industry guidelines, standards and safety requirements.
* Ability to read and interpret P&IDs and identify boundaries.
* Working knowledge of and ability to apply GMP, GCP, GLP, GAMP.
* Proficient with Microsoft Word, Excel, PowerPoint, Visio and Project.
* Hands-on experience working as a productive and supportive member of a project team.
* Possesses validation experience.
* Detail oriented. Completes work tasks and documentation with minimal errors.
* Ability to work independently or on a team.
What you will get:
Attractive rates, while working in a multi-disciplinary environment, in a vibrant expanding international company.
#J-18808-Ljbffr