Job Description
We are seeking a highly skilled CQV Engineer to join our team at PM Group's Outsourced Technical Services (OTS) department. The successful candidate will be based on our client's site in Co. Wicklow and will be responsible for driving several Capex projects to completion.
Main Responsibilities
* Commissioning, Qualification, and Validation Testing: Performs testing under the supervision of a Sr CQV Specialist, CQV Engineer II, or Senior CQV Engineer on utilities, manufacturing process equipment, and instruments.
* Protocol Authoring: Writes protocols and initiates controlled documentation as part of a team.
* Document Development: Develops master plans, design qualification, equipment, facility, and utility commissioning documents and final reports under direct or indirect supervision.
* Client Interaction: Works with clients to identify needs and develop solutions that meet schedule, cost, and quality expectations based on Good Engineering Practices.
* Project Planning and Execution: Follows project planning, management, and execution schedules.
* Equipment Testing and Analysis: Tests equipment accurately and develops an understanding of how instruments work.
* Investigations and Reporting: Investigates failures and deviations and creates reports.
* Spare Parts Review: Analyzes and reviews spare parts lists to ensure they are fit for purpose.
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* CAPAs and Recommendations: Assists with Corrective and Preventative Actions and makes recommendations to resolve deficiencies.
Key Qualifications
* cGMP Understanding: Clear understanding of cGMPs and pharmaceutical operations.
* Commissioning and Qualification Principles: Understands and applies principles of commissioning and qualification.
* Analytical and Organizational Skills: Strong analytical, organizational, time management, and problem-solving skills.
* Communication Skills: Excellent writing skills and ability to develop and execute validation and quality policies, procedures, and guidelines.
* Industry Knowledge: Basic understanding of working in a construction environment and knowledge of current industry guidelines, standards, and safety requirements.
* P&ID Interpretation: Ability to read and interpret P&IDs and identify boundaries.
* Regulatory Compliance: Working knowledge of GMP, GCP, GLP, and GAMP.
* Technical Skills: Proficient with Microsoft Office Suite and Visio.
* Teamwork and Attention to Detail: Ability to work independently or on a team and maintain high levels of attention to detail.
What We Offer
A competitive remuneration package and the opportunity to work in a dynamic international company with a multi-disciplinary team.