Sr. 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 Sr. Engineering Manager with a biotech 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

FULL DESCRIPTION :

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 stable site operations as required for 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 within intended timeframes. Manage the implementation of new technologies to improve manufacturing processes.
  • Oversee the development and initiation of programs for future production equipment and facility upgrades, including identification and corrective action required to improve existing equipment and 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 with 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.
  • Direct knowledge of FDA cGMP regulations/requirements for facilities and utilities within manufacturing.
  • Experience in creating GMP documentation (Deviations, Changes, CAPA, Qualification, etc.).
  • Knowledge of PSM, safety and safety regulations (e.g. OSHA).
  • Excellent oral and written communications skills.
  • Project management experience is strongly desired.
  • Extensive experience with digital solutions for the manufacturing industry, including business system solutions, control systems, and data historians.

Salary Range: $150k-165k/yr

For immediate and confidential consideration, please email your resume to or call 858.866.8676. More information can be found at .

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