Job Description
KEY RESPONSIBILITIES:
- 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 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.
- Must exhibit mechanical abilities including tool familiarity, lifting, climbing a ladder and gown into cleanrooms
IDEAL CANDIDATES:
- 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
PREFERRED QUALIFICATIONS
- 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.