Senior C&Q Engineer & Kneat Paperless Implementation Specialist

Company: VEQTOR
Location: Raleigh
Posted on: June 25, 2022

Job Description:

VEQTOR is currently looking for a Senior C&Q Specialist / Engineer who have demonstratable C&Q and validation background and who wants to get involved with application and execution of risk-based methodologies and moving towards digitization of C&Q and validation process into Kneat Gx Platform.The ideal candidate will serve as Subject-Matter-Expert with commissioning, qualification, and validation principles, testing on manufacturing process equipment, HVAC, cleanrooms, utilities, warehouse, cold storage units and instruments coupled with automated process controls (i.e., PCS, PLC).Responsibilities will include C&Q oversight and requires extensive interaction with clients to identify C&Q needs and work towards solutions that meet schedule, cost, and compliance expectations and requirements. Build a high level of trust with internal and client personnel. This trust is developed through consistently upholding VEQTOR values and demonstrating honesty, integrity, pride, accountability, teamwork, and commitment.In this position, the ideal candidate will be integrated into VEQTOR's C&Q group and Kneat Services & Support group working on the projects (internal and external) for our US and EU clients.KNEAT Gx platform digitizes and manages life cycle documentation, including design documentation, risk management, commissioning and qualification, validation documentation and testing. It releases groups from paper and is presently being used by 12 of the world's top 20 pharma companies. Being part of the VEQTOR team you will be trained on KNEAT and assist our clients with implementationDesired Skills & Experience:

• Serves as a Subject-Matter-Expert (SME) for commissioning and qualification and has a proven history of successful implementation of various manufacturing and utility systems, CIP & SIP, autoclave validation, qualification of controlled temperature environments, process validation, cleaning validation, equipment qualification.
• Familiarity with ASTM E2500 risk-based C&Q strategies, procedures, policies, and guidance and its practical applications based on process knowledge and product requirements.
• Work with VEQTOR's Kneat Service and Support group to implement paperless solutions to our clients in US and support remotely Kneat related projects. In time, the ideal candidate will be trained as a master trainer and lead implementations.
• Author protocols, initiate controlled documentation, and provide client support for C&Q projects either independently or as part of a larger team.
• Lead generation of documents such as C&Q plans, design qualification, equipment, facility and utility commissioning and qualification protocols, data reviews, SOP development, and development of final reports.
• Proven project and people leader with exceptional skills in planning, organizing, and history of driving and delivering successful results.
• Exceptional communication skills between team members, clients, and project leads.
• Industry expert on C&Q trends, compliance and regulatory issues and requirements, ability to convey and conform systems and processes.
• Independently and with minimal oversight initiates, establishes, provides direction, execution, and follow up of commissioning, qualification, calibration, and validation projects.
• Shows initiative and the ability to consistently follow-through.
• Able to perform commissioning, qualification, and validation testing on manufacturing process equipment, HVAC, cleanrooms, utilities, warehouse, cold storage units and instruments coupled with automated process controls (i.e., PCS, PLC)
• Knowledge of minimal protocol requirements and ability to author various life cycle documents associated with C&Q and Validation
• Ability to generate project budget proposals based on a client's Request for Proposals (RFP)
• Provides project planning, management, execution, and follow up.
• Reviews equipment specifications, manuals, and develops an understanding of how an instrument works; tests equipment to accurately verify it is working as intended.
• Ability to investigate failures and deviations.
• Perform a spare parts review, fit for purpose, and analysis.
• Reviews design and requirement specifications to establish fit-for-purpose for systems.
• Reviews engineering drawings for accuracy.
• Ability to perform system walk-downs, as well as other engineering pre-commissioning activities, if required.
• Assist all VEQTOR team reports and client reports on preparation and review of project C&Q deliverables.
• Working alongside clients on performing change control of processes.
• Initiates and resolves client Corrective and Preventive Actions (CAPAs).
• Provides summary and analyses reports
• Liaising with contractors, suppliers, and internal company stakeholders
• Perform ongoing reporting of the project progress to client and VEQTOR management
• Ensuring all aspects of the project proceed while adhering to company SOPs as well as external regulations, including maintenance of project documentation
• Ability to troubleshoot problems as they arise on a project - finding efficient and effective solutions
• Knowledge of Validation policies and documentation for various systems and processesOther Required Skills & Abilities:
  • B.S. in -Science or Engineering discipline
  • Minimum of 7+ years related experience preferred
  • Detail oriented, self-motivated and a team player
  • Ability to work in a fast-paced, high-energy environment
  • Developed inter-personal communication skills and has the ability to communicate project activities and schedules with multiple functional groups (i.e. Quality Assurance, Operations, Regulatory) and client Senior Management teams
  • Ability to perform critical analysis of situations and provide recommendations
  • Problem solving, creative thinking, and interaction with upper management and design teams
  • Experience in pharmaceutical is plus
  • Ability to work independently with structured guidance
  • Possess excellent interpersonal, organizational, writing and communication skills
  • Ability to adhere to client-specific safety policies and procedures, as well as OSHA requirements.

Keywords: VEQTOR, Raleigh , Senior C&Q Engineer & Kneat Paperless Implementation Specialist, Engineering , Raleigh, North Carolina