VEQTOR is currently looking for a C&Q Specialist/Engineer/Independent Consultant with experience working on technical and engineering projects such as commissioning, qualification, and validation of Facilities, Utilities, Equipment (i.e. incubators, isolators, automated fill lines, inspection machines, packaging equipment, autoclaves, bioreactors, filter presses, lyophilizers, spray dryers), and manufacturing processes to work at multiple client sites in the following locations:
- Chicago, Illinois
- Puerto Rico
- North Carolina
- Southern California
These positions will be responsible for the generation of design documents (i.e. URS, C&Q Plan, risk assessments), authoring protocols, execution of commissioning and qualification activities, along with moving these methodologies towards digitization of C&Q and validation processes into the Kneat Gx Platform. The position will also have the ability to provide client support for C&Q projects either independently or as part of a site team. This position will have the ability to interpret the needs, expectations, and limitations of each stakeholder, and bring them together with the goal of meeting project timelines. They should have familiarity with risk assessments and overall project safety. They must have prior experience in pharmaceutical or similar regulated cGMP environments and experience in supporting fast-paced C&Q/validation projects, development of documentation, and/ or execution of various C&Q/validation projects. They should be able to build a high level of trust with internal and client personnel. Candidates must operate with honesty, integrity, 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 implementation.
These roles are primarily on-site but there may be hybrid or remote options available depending on client and project need.
The ideal candidate should have the following skills:
- Ability to identify project requirements from client stakeholders to achieve the desired outcome.
- Ability to generate a detailed plan that can be implemented by a project team.
- Plan, communicate and lead scientifically sound C&Q strategies for small to large scale projects.
- Familiarity with risk-based C&Q strategies, procedures, policies, and guidance and its practical application based on process knowledge and product requirements.
- Aptitude to plan (i.e., budget/scheduling) and forecast a project from a C&Q and/or Validation perspective.
- Capable of understanding project needs.
- Liaising with contractors, suppliers, and internal company stakeholders.
- Ability to perform system walk-downs, as well as other engineering pre-commissioning activities, if required.
- Able to perform commissioning, qualification, and validation testing on manufacturing process equipment, such as:
- Incubators/Coolers/Freezers/Freezer Dryers/Autoclaves
- Mixers including single-use
- Bioreactors/Product Vessels/Buffer Vessels
- Fume Hoods/Biosafety Cabinets
- Able to perform commissioning, qualification and validation testing on facilities and utilities, such as:
- Nitrogen, Clean Compressed Air, Vacuum, RODI, Purified Water, Water-For-Injection, Clean Steam
- HVAC, Cleanroom Qualification
- Knowledge of minimal protocol requirements and ability to author various life cycle documents associated with C&Q and Validation.
- Perform a review of design and requirement specifications to establish fit-for-purpose for systems.
- Perform a review of engineering drawings for accuracy.
- Provide summary and analyses reports.
- 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.
Desired Skills & Experience:
- Knowledge of Validation policies and documentation for various systems and processes
- B.S. in Science or Engineering discipline
- Minimum of 3 – 5+ years related experience preferred, however candidates with related experience will be considered
- Kneat Gx platform experience is preferred but not required
- Proficient in English
- The candidate will be required to be trained in VEQTOR policies and procedures, as well as client-site policies and procedures, and adhere to both
- VEQTOR is considering C2C and Independent Consultants for these opportunities
- Job Types: Full-time or Contract