Address
Form of workResponsibilities:
- 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 the degree of innovative exploration with pursuit of project objectives and coordinates implementation / integration of new capabilities as appropriate.
- B.A, B.S. in Engineering or related discipline with at least 5 years of relevant experience or M.S. in related field with 3 years of experience.
- 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, preferably oral solid dosage, or related experience.
- Extensive hands-on experience dealing with change controls.
- 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.
- Demonstrate planning and organizational skills, including complex project management.
- Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc)
- 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.
- Ability to review Engineering Document and Models (CAD, Revit etc.)
- Ability to use Project Management tools.
