CQV Engineer role will lead and coordinate the CQV project activities for the Solution Preparation area in line with the site project strategy. The CQV Engineer will work across all project functions including but not limited to process engineering functionally across Operations, Operational Engineering, Quality Operations, EHS, Logistics, Lean & Digital to understand their functional requirements and develop and execute the optimum validation strategy.
MAIN DUTIES AND RESPONSIBILITIES:
* Guide CQV activities for solution prep, ensuring timely execution and compliance with industry regulations.
* Develop, review, approve and execute the commissioning, installation and qualification protocols ensuring all issues identified during execution are managed correctly, efficiently and in accordance to site / project procedures.
* Generate, review and approve Validation Plan, SRA, DQ, URS's etc.
* Manage and coordinate Solution Prep equipment commissioning and qualification activities.
* Review and approve vendor/ field turnover packs for all equipment associated to Solution Prep area.
* Act as the CQV point of contact between clients, internal teams, and external vendors to drive project success.
* Provide technical oversight and guidance to resolve issues has they arise in a collaborative manner.
* Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
PRINCIPAL QUALIFICATIONS/SKILLS AND WORK EXPERIENCE REQUIRED:
* Clear understanding and previous experience in deployment and execution of a RBV (Risk Based Validation) process in line with the ISPE guidelines in a large Capex Environment.
* Experience of a digitized C&Q platform i.e. Kneat Solutions
* Solution driven mindset in a fast-paced dynamic environment.
* Previous experience with vendors such as BCD, Hetch, Rockwell and / or solution preparation/ formulation experience.
* Previous experience as senior CQV Engineer with a technical background.
* Relevant qualification (Degree) and /or relevant experience of 10 +years in biotech/pharmaceutical industry qualifying GXP systems.
* Clear understanding of regulatory requirements for EU and other regulatory bodies ensuring CQV is delivered meeting all regulatory requirements and guidelines.
* Excellent verbal and written communication skills, Experience in developing a strong working relationship with other departments.
* Strong analytical problem-solving skills. Dynamic decision maker, effective planner, and communicator