Job Summary:
VEQTOR, a life sciences engineering services company, is looking for a CQV Engineer II to cover numerous client and internal team CQV-based projects. This role is a pivotal role within the organization to continue to develop and maintain the C&Q side of the business.
CQV Engineer serves as an mid-level/senior engineer with industry and guidance-based knowledge and experience commissioning, qualification, and validation risk-based principles, testing on manufacturing process equipment (upstream, downstream, formulation, fill/finish), HVAC, cleanrooms, utilities, warehouse, cold storage units and instruments coupled with automated process controls (i.e., PCS, PLC). The engineer will author protocols, initiate controlled documentation, and provide client support for C&Q projects either independently or as part of a larger team. The position requires extensive interaction with clients to identify C&Q needs and work towards solutions that meet schedule, cost, and compliance expectations and requirements. The engineer shall 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.
This role will report directly to a CQV Lead or Manager.
These are the key functions this role will have direct accountability for:
- On smaller-scoped projects, as determined by VEQTOR management, ability to lead VEQTOR internal CQV/CSV teams (act as project lead/manager)
- Workforce and resource planning
- Deliverables tracking
- Budget tracking
- Main VEQTOR client liaison
- Generation of documentation such as C&Q Plans, user and design specifications, DQ, FUE CQV protocols, procedures and policies, and final reports,
- Perform data reviews to determine testing acceptance,
- Perform execution activities as defined via protocol,
- Ability to troubleshoot problems as they arise on a project – finding efficient and effective solutions,
- Review equipment specifications, manuals, and develops an understanding of how an instrument or system works and then able to apply this to developing sound testing to confirm the system works appropriately,
- Identify key clients and CAPEX project opportunities,
- Ability to investigate failures and deviations,
- Reviews design and requirement specifications to establish fit-for-purpose for systems,
- Facilitate client’s meetings on a project-by-project basis,
- Ensure successful outcomes from client’s meetings by following up with key decision makers,
- 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,
- Liaising with contractors, suppliers, and internal company stakeholders,
- Perform ongoing reporting of the project progress to client and VEQTOR management.
Essential Job Functions and Duties:
- Familiarity with ISPE Baseline, ASTM E2500 risk-based C&Q strategies, procedures, policies, and guidance and its practical applications based on process knowledge and product requirements,
- Proven professional with exceptional skills in planning, organizing, and history of driving and delivering successful results,
- Independently and with minimal oversight initiates, establishes, provides direction, execution, and follow up of commissioning, qualification, calibration, and validation projects,
- 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,
- Knowledge of minimal protocol requirements and ability to author various life cycle documents associated with C&Q and Validation,
- Support VEQTOR’s implementation of Kneat Gx+ platform for client specific projects,
- Support other internal VEQTOR projects and initiatives.
Other Required Skills & Experience:
- 3 to 7 years of experience in pharmaceutical and biotech sectors preferred,
- B.S. in Science or Engineering discipline,
- Ability to work in a fast-paced, high-energy environment,
- Ability to perform critical analysis of situations and provide recommendations,
- Ability to adhere to client-specific safety policies and procedures, as well as OSHA requirements,
- Shows initiative and the ability to consistently follow-through,
- Experience working with paperless validation software (i.e., KNEAT, ValGenesis),
- Possess excellent interpersonal, organizational, writing and communication skills.
