CQV Specialist III

Overview

Deliver cGMP commissioning, qualification, and validation services for pharma/biotech projects.

Key Responsibilities

• commissioning
• vendor testing
• system walkdown
• c/q/v
• fat/sat
• report preparation

Tasks

-Execution of commissioning forms and witnessing of vendor start-up and testing. -Work with the Project Delivery department or CM for start-up and vendor testing. -Promotes a friendly and efficient work environment, which rewards achievement and recognizes teamwork and champion’s technical advancement, which supports our corporate goals. Maintain professional conduct and deliver services in a professional and acceptable fashion. -Position will visit Client sites and will be required to adhere to stated safety rules. -Perform field/site activities including, but not limited to, the following: -Works in conjunction with department management in recruiting new staff members and promoting IPS to potential hires (focused on cleaning and process validation). -Walkdown and verification of system drawings (P&IDs, as-builts, etc.) -Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services -Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. -Execution of C/Q/V protocols. -Position may visit active construction sites and will be required to take site safety training and adhere to site safety rules. -Attend and witness FATs and SATs as a representative of IPS clients. -Supports and deploys technical training programs that assure competency and advancement levels to support corporate goals. -Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested. -Assist in deviation investigation and resolution of problems and issues encountered during field execution activities. -The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research or other "non-administrative" areas. -Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc. -Write C/Q/V documents following established standards and templates, including but not limited to the following:

Requirements

• gmp
• validation
• pharma
• ms office
• 5+ yrs
• bachelors

What You Bring

-Must exhibit the ability to build and sustain long term relationships of mutual value through teamwork. -Good interpersonal skills -General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA helpful. -C/Q/V Protocols and Summary Reports -Associates or Bachelor degree in related field preferred -Able to multi-task -Effective time management -Overnight travel or staying in the city of Client’s location is possible depending on assignment. -Excellent customer service skills -Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software a plus. -This position will have up to 100% travel, or as required by the assigned project. -Sense of urgency -Attention to detail -Proficiency with Microsoft Office applications (Word, Excel, Project, Powerpoint, etc). -5 or more years of relevant experience. -Able to effectively prioritize -Specifications (URS/FRS/DDS) -Must display creativity and innovation by continually working to improve solutions, tools, methods and service delivery system.

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Benefits

-Travel will be per the IPS Travel Policy, client specific travel policy or project specific travel plan.

About Ips-Integrated Project Services

-Founded with the vision of delivering exceptional project solutions, the company is a trusted partner in the global construction and engineering sector. -From concept to completion, the company offers comprehensive services across various industries, including industrial, energy, infrastructure, and commercial sectors. -The company has a rich history of delivering large-scale, complex projects, with a focus on high-quality standards, safety, and sustainability. -Specializing in end-to-end project delivery, the company ensures that projects are managed efficiently, from initial planning through to construction and commissioning. -Notable for its ability to handle both small-scale and large-scale ventures, the company is recognized for its expertise in managing projects for major players in energy and industrial markets. -The company's deep technical expertise allows them to bring innovative solutions to life, working across sectors like nuclear, water resources, and heavy civil engineering. -With a solid track record in the design and build of cutting-edge facilities, the company stands out for its dedication to technical excellence and client satisfaction.

Sector Specialisms

Interview Process

-all interviews are conducted either in person or virtually, with video required.