Sr Mechanical Engineer
BioSpace · New Albany, OH · 1 wk ago
EngineeringFull-time
Responsibilities
- Provide leadership for 24/7 field support to identify, and resolve utilities and facilities issues.
- Own the equipments and/or systems related to the site utilities.
- Have deep technical understanding of (Boilers, Chillers, Compressed Air, and HVAC).
- Stay in sync with Current Good Manufacturing Practices to ensure utility systems are compliant.
- Own and maintain related drawing and P&IDs.
- Provide coaching and technical expertise to the technicians to support the infrastructure operations.
- Identify and implement opportunities to improve equipment & process reliability and minimize impact of maintenance activities to ongoing operations.
- Provide leadership to continuously improve strategies throughout the site and across all shifts.
- Collaborate with key customers and support groups regarding operations & maintenance activities and strategies.
- Collaborate with Facilities & Engineering peers within the Amgen manufacturing network.
- Ensure activities are accomplished in a safe manner in accordance with cGMP requirements and expectations.
Qualifications
- Doctorate degree
- OrMasters degree and 2 years of Maintenance or Engineering experience
- OrBachelors degree and 4 years of Maintenance or Engineering experience
- OrAssociates degree and 8 years of Maintenance or Engineering experience
- OrHigh school diploma / GED and 10 years of Maintenance or Engineering experience
- Bachelors Degree in Mechanical Engineering preferred
- 6+ years experience in engineering or maintenance or related function within the biotechnology and/or pharmaceutical and/or medical device industry preferred
- 5+ years experience and track record of ensuring compliance in a highly regulated environment preferred
- 5+ years experience in engineering project management preferred
- 5+ years experience in process and/or machine validation preferred
- 5+ years experience in CAPA process management preferred
- Technical experience with critical and non-critical utilities systems (Example: HVAC, Compress Air, Boilers, etc.) preferred
- Ability to manage multiple tasks and optimally set priorities preferred
- Technical writing skills preferred
- Established Leadership capabilities preferred
- Passion for Operational Excellence preferred
- Financial savvy preferred
- Communications skills, both oral and written, including executive presentation skills preferred
- Interpersonal and facilitation skills to forge consensus among competing client interests while ensuring objectives are met preferred
- Ability to tactfully negotiate and positively influence peers and executive leadership preferred
- Analytical skills to identify potential improvement opportunities preferred
- Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, etc.) preferred