Facilities Engineering Manager - Simply Biotech - TalentZok
San Diego, CA
About the Job
Facilities Engineering Manager- Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Facilities Engineering Manager with a biopharmaceutical company in San Diego, CA who possesses:
- Bachelor's degree in chemical engineering or biological engineering and 6+ years of industry experience
- Extensive experience with hands on validation of facilities and manufacturing equipment within biotech
- CSV experience is a plus
- Hands-on engineering background is a plus
Email resumes to orion@simplybiotech.com or call 858.866.8676
FULL DESCRIPTION: This position will oversee maintenance of the GMP facility, ensuring that they meet operational needs and comply with relevant regulations and standards. The Facilities Engineering Manager will be responsible for: Facilities Site Services, Metrology and Validation.
The selected candidate will be responsible for:
- Manage all operational aspects of the Engineering, Maintenance, Calibration, Qualification and Facilities services, including security and access management and ongoing coordination with site landlord management team.
- Manage employee relations including recruit, mentor, and develop a high-performing engineering team to implement best practices and continuous improvements
- Ensure a technical organization that supports stabile site operations as required for the manufacturing and process/ facility improvements. Oversee the management of engineering cost centers, capital investment and technical expense budgets
- Collaborate with cross-functional teams to identify and address facility and equipment-related needs and improvements aligned with business objectives.
- Conduct regular inspections, risk assessments, and audits to identify potential hazards, non-compliance issues, and areas for improvement.
- Identify and implement opportunities for performance and cost improvement, develop solutions to recurring or potential problem areas and establish necessary contingency plans. Cultivate an efficient, professional and safe working atmosphere and ensure objectives are met with intended timeframes. Manage the implementation of new technologies to improve manufacturing processes.
- Write, support and manage deviations, investigations and CAPAs related to GxP maintenance, utilities and building automation systems.
- Assist with troubleshooting to prevent or minimize production upsets and/or downtime
- Support internal and external audits
- Follow and manage operational EH&S and security systems
- Perform all tasks and assignments in accordance to company policies and procedures
The selected candidate will also possess:
- Bachelor's degree in Engineering discipline. Master´s degree preferred
- Minimum 10+ years of engineering and/ or facilities and/ or maintenance management experience in the biotechnology or pharmaceutical industry
- Significant experience in the engineering and maintenance of manufacturing facilities and equipment for GMP regulated production and experience in life cycle asset strategies
- Travel as necessary
- Extensive knowledge of GMP plant facilities, utilities, and manufacturing equipment.
- Advanced leadership competencies which support the rigidity of GMP operations against the competing demands of a CDMO environment.
- Excellent ability to manage multiple projects and priorities in a fast-paced environment and meet required deadlines
- Experience in creating GMP documentation (Deviations, Changes, CAPA, Qualification etc.)
- Knowledge of PSM, safety and safety regulations (e.g. OSHA)
Salary Range: $150-$180k/yr
For immediate and confidential consideration, please email your resume to orion@simplybiotech.com or call 858.866.8676. More information can be found at www.simplybiotech.com
For immediate and confidential consideration, please email your resume to orion@simplybiotech.com or call 858.866.8676. More information can be found at www.simplybiotech.com
Source : TalentZok