Reporting to the Operations Director, the Sr. Manager of Plant Engineering is a key member of the Operations team responsible for Wacker Biotech US' cGMP manufacturing facilities, laboratories, equipment, and offices.

This position will oversee maintenance of the GMP facility, ensuring that they meet operational needs and comply with relevant regulations and standards. The Sr. Manager of Plant Engineering will be responsible for : Facilities Site Services, Metrology and Validation.

Wacker is a safety-first organization, and this position will also be critical in maintaining a safe work environment.

Essential Functions of this Position:

• 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 Wacker's policies and procedures

Required Education and Experience:

• Bachelor's degree in Engineering discipline. Masters 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

Critical Knowledge, Skills, and Abilities:

• 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)

Additional Requirements:

• 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.

The anticipated salary range for candidates who will work in San Diego is $120,000.00- 170,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc . Wacker is a multi state employer and this salary range may not reflect positions that work in other states.

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement