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
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