Plant Engineer III
Wacker
- San Diego, CA
- Permanent
- Full-time
- 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.
- 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
- 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
Reference Code: 26861#LI-CE1The 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.