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Senior Manager of Plant Engineering 1 - San Diego California
Company: Wacker Chemie AG Location: San Diego, California
Posted On: 02/02/2025
Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.We are looking for you as a(n) Senior Manager of Plant Engineering 1.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 recruitment, mentoring, and developing 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 actions 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 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:
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