- Execute change management for manufacturing equipment and other support systems including commissioning and/or implementation of other related initiatives as assigned.
- Manage creation, revision and review of Protocols, Reports, and Engineering Documents including, but not limited to, IOV, drawings, user requirement specifications and SOPs.
- 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.
- Must exhibit mechanical abilities including tool familiarity, lifting, climbing a ladder and gown into cleanrooms
- Demonstrate planning and organizational skills, including complex project management.
- Ability to lead by influence.
- Foster change and innovation - Seeks solutions that strengthen quality, value, service and effectiveness
- Demonstrate business acumen and business agility - Demonstrates functional/technical proficiency, engages in effective operational and strategic planning
- Accountable for Results Translates goals/objectives into actionable plans and results
- Able to work on multiple projects and manage various priorities and timelines
- Demonstrates proficiency in the following competencies: Responsive to change Adapts (quickly) to changing circumstances Model collaboration and commitment Focuses on team success before individual success.
- Demonstrates operational excellence Continually looks for new and better ways to get things done and shows functional/technical proficiency in work.
- Demonstrates effective self-management Seeks to understand and act upon improvement opportunities.
- Ability to review Engineering Document and Models (CAD, Revit etc.)
- Ability to use Project Management tools
- B.A, B.S. in Engineering or related discipline with at least 5 years of relevant experience or M.S. in related field.
- 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
- Excellent verbal and written communication skills applied on a global or multi-national basis.
- Strong interpersonal skills, including the demonstrated ability to manage through influence
Facilities Site Engineer - Boston, United States - Trinity Consultants
Description
Facilities Site Engineer (Biotech)
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
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