Facilities Compliance/ CQV Engineer
ADVENT Engineering, a Trinity Consultants company, is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Head-quartered near San Francisco, California, and with operations in the Eastern US and Canada, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.
ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.
The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.
This is an outstanding opportunity to join our growing team!
The role entails the primary job functions:
- Deviation Author/Coordinator - Support site investigations for facility and equipment which includes overseeing the closure of investigations, which includes the management, tracking, handling, and reporting of progress updates as required.
- Technical Author/Coordinator - Support the coordination and writing/revision of technical writing needs for the facilities team which include but are not limited to the following documents; SOPS, Work Instructions, Change Controls.
- CMMS Coordinator - Provide support with regard to the CMMS program which include but are not limited to the following tasks; perform work record reviews, perform equipment information updates, create and revise work plans.
- HVAC Coordinator/Reviewer - Provide oversight of vendor executed work deliverables which may include (but is not limited to), escorting/hosting the vendor on site, a cGMP audit and review of vendor executed/provided documents, vendor cGMP oversight during execution.
All roles will entail excellent communication skills with all groups across the site, highly developed written and verbal skills, professionally liaising between area management and Quality Assurance, adherence to all levels of compliance within the Biopharma industry, a high level of organization abilities.
- 3+ years of experience in biotech-pharmaceutical academic or industrial environment
- Experience with Clean Utilities, Process Utilities, HVAC, CTUs, upstream and downstream process equipment and/or Metrology/Calibration,
- Experienced with upstream and downstream bioprocess operations, and fill-finish systems
- Demonstrated experience with manufacturing processes and equipment such as CIP systems, filtration skids, chromatography and lyophilization equipment
- Provide leadership and expertise in projects and coordination and stakeholder communication / management
- Experience in either commissioning, validation or engineering is preferred
- Engineering degree in Chemical Engineering, Biochemical Engineering or Mechanical Engineering. Life Sciences degree as applicable (e.g. Biochemistry, Chemistry, Biology).
- Travel within USA as needed for the projects
- Permanent FTE (preferred) or temporary/contract options are possible
Candidates please note: Kindly ONLY apply if you meet the experience expectations described: Experience in GMP pharmaceutical and/or biotechnology facilities in design, engineering, quality or manufacturing is a MUST. Candidates with direct related experience interested in US or Toronto locations are encouraged to apply.