- Provide technical leadership on design, commissioning, and start-up of control systems supporting manufacturing, testing, and storage of biotech and pharmaceutical processes, systems, and facilities. Undertake technical reviews for documents generated by others to ensure that technical and regulatory requirements are met.
- Working with full range of Biotech/pharma project phase execution including all design phases (conceptual design, basic design, detailed design), construction support and commissioning. You may support CQV (Commissioning, qualification and validation), shut-down, and project hand-over activities.
- Generating, revising, and troubleshooting automation code and associated specifications and drawings as required.
- Support field wiring diagram verifications, loop testing, change owner responsibilities and workplan field test documents using MS Access
- Performing code review to ensure code meets its specifications and requirements and is fit for purpose
- Assisting process and validation teams in execution of process, cleaning, equipment, and utility C&Q efforts.
- Writing and executing commissioning and/or qualification protocols and associated reports to verify systems are qualified for use
- May require oversight, management, and partnerships with process and equipment engineers to provide guidance and leadership to colleagues in technical aspects, thoroughness and detail oriented in ensuring fulfillment of project deliverables of team.
- You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and ADVENT resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
- 10+ years of experience in biotech, pharmaceutical, medical device, or academic or environment
- Experience with contemporary process control systems such as DCS (Delta V, ABB, Rockwell), BAS (Siemens, Schneider, Honeywell), PLC (Rockwell, GE, ABB), and SCADA (iFix, FT)
- Experience with plant floor historian databases, interfaces, and reporting tools such as OSI, iHistorian, and SQL Server.
- Experience writing, reviewing, and updating design and functional specifications.
- Experience writing and executing commissioning and verification protocols and associated reports
- Familiar with integrated commissioning and validation as well as ASTM E2500 verification methods
- Experience utilizing risk based methodologies in testing
- Experience with manufacturing processes and equipment such as CIP/COP systems, filtration skids, chromatography, fermentors/bioreactors, sterilization, and lyophilization equipment
- Experience with hygienic utility systems such as purified water, WFI, clean steam, and process air
- Experienced with Office software such as Word and Excel
- Engineering or Scientific degree
- Travel may be required on occasion
- Permanent FTE or temporary/contract options available
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DeltaV Automation Engineer - California, United States - Trinity Consultants - Advent Engineering Life Science Solutions
1 week ago
Description
POSITION: Sr. DeltaV Automation Engineer
LOCATION: San Francisco Bay Area
ADVENT Engineering 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
RESPONSIBILITIES
QUALIFICATIONS
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.