Facilities Site Engineer (Biotech/Pharma)
Location – Boston
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 and Western US, Canada and Singapore, 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!
Key responsibilities:
- Execute change management for manufacturing equipment and other support systems including commissioning and/or implementation of other related initiatives as assigned.
- Execute assigned duties on time and within budget; pro-actively communicate delays and other issues to relevant stakeholders.
- Manage creation and revision of protocols, reports, and engineering documents including, but not limited to, IOV, drawings, user requirement specifications and SOP's.
- Effectively work with cross departmental stakeholders to achieve departmental goals and objectives
- Supply GEP (Good Engineering Practice) expertise drawn from own experience and/or supplemented by external resources to trouble shoot facility, equipment, or system issues.
- Balance degree of innovative exploration with pursuit of project objectives and coordinates implementation / integration of new capabilities as appropriate.
Ideal candidates:
- Demonstrate planning and organizational skills, including complex project management.
- Demonstrate business acumen and business agility - Demonstrates functional/technical proficiency, engages in effective operational and strategic planning.
- Able to work on multiple projects and manage various priorities and timelines.
- Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.
- Knowledge of facility related engineering disciplines (MEP) in GMP manufacturing environment