Wacker Biotech is seeking a highly organized and motivated team member to join our Plant Engineering Team.

The position reports to the Sr. Manager of Plant Engineering and serves as a subject matter expert in the facilities operation, maintenance and qualification of Wacker Biotech USs GMP facility and equipment. This position will work closely with other functional team leaders and associates to ensure the operation of validated environment(s) according to GMP and other regulatory requirements.

Wacker is a safety-first culture, the Plant Engineer II will be responsible in maintaining a safe work environment, following all safety rules and wearing appropriate PPE when needed. Identifying any potential safety issues and reporting such issues and assist in rectifying, if applicable

Essential Functions:

*Technical and organizational implementation of equipment and plant commissioning

*Monitoring the equipment, equipment status and equipment performance to ensure production quantities and quality/safety. Initiate corrective actions in case of deviations in quantity, quality and safety.

*Author qualification documents such as (Validation Plan (VP), Users Requirement Specifications (URS), Design and Configuration Specification (DACS) Installation/Operation Qualification IOQ, Performance Qualification (PQ), Final report and Requirement Traceability Matrix (RTM).

*Develop and execute validation process and studies that are compliant with established procedures and aligned with regulatory requirements and industry best practices. As needed perform technical qualification of existing and new equipment

*Prepare and supervise routine repair and maintenance activities, including major shutdowns. Preparation of checklists, plans, etc.

*Coordination of service companies regarding approval of work steps and on-site inspections

*Develop, author, maintain and conduct , standard operating procedures, risk assessment, change controls, CAPA, Quality Incidents and deviations.

*Perform regular inspections to ensure continuous EHS and GMP compliance of the facilities.

*Assist in the planning and prioritization of development and production projects. Assist in the planning of new facilities. Manage internal engineering projects

*Support the Director of Plant Engineering in the planning and coordination of investments (CAPEX planning, etc.) of the department.

Position Requirements:

• Bachelor's degree in engineering (mechanical, electrical, or related field)
• Minimum of 5 years of direct facilities and engineering, building operations or facilities management experience in the biotechnology or pharmaceutical industry.
• Strong technical knowledge of mechanical, electrical, building automation, qualification and safety system
• Experience and comfortable in a fast-paced, collaborative small company environment, working with minimal direction and able to adjust workload based upon changing priorities

Critical Knowledge, Skills, and Abilities:

• Prior experience with cGMP requirements
• Ability to work successfully with all team members in a fast-paced environment
• Excellent written and verbal communication skills, including the ability to interact effectively with technical experts and non-technical stakeholders
• Experience and ability to work optimally in a multi-tasking team and fast pace environment, with skills on prioritizing, delivery and being flexible in response to change
• Ability to provide expert advice and clear recommendations, and to propose insights and develop solutions to sophisticated problems

The anticipated salary range for candidates who will work in San Diego is $81,000.00- 101,000.00. 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