Sr. Engineering Manager - SimplyBiotech

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 Email resumes to odrow@ 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 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.-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 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-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 ()-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 odrow@

Salary : $150,000 - $165,000