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. 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
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.
What do we offer? WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions. WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development. 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 We are looking forward to your online application at www.wacker.com.Reference Code: 28420 #LI-CE1 The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a green card). WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.