Summary Sheet: Trades & Services
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|Advertiser Name||Just - Evotec Biologics||Advertiser Type:||Agency|
|Classification:||Trades & Services||Subclassification:|
|Country:||United States||Location:||United States|
|Language:||English - United Kingdom (en-GB) ||Contact Name:|
|Employment Type:||Permanent||Workhours:||Full Time|
Position: GMP Facilities Manager
Just is seeking a highly motivated, detail oriented and driven GMP Facilities Manager that desires a significant opportunity to improve worldwide access to biotherapeutics. This position will provide technical support the manufacturing facilities by ensuring manufacturing equipment, plant utilities and facilities are operating within specifications to meet the requirements for biopharmaceutical manufacturing.
- Prioritize, plan, coordinate and schedule corrective, preventive, and predictive maintenance work for the assigned maintenance areas, with internal and external service providers, ensuring adherence to Safety and Quality best practices.
- Work with external maintenance vendors, contractors, and suppliers to provide the site with quality services.
- Manage maintenance activities and work order backlog in the CMMS system to ensure that all system data are updated, accurate, and compliant following approved procedures.
- Responsible for timely procurement and acquisition of parts needed for planned maintenance.
- Responsible for the day-to-day coordination of calibration activities, testing, and troubleshooting process control instrumentation in compliance ISO (9001 & 17025), ANSI/NCSL Z540 and Just-Evotec Standard Operating Procedures.
- Investigate equipment and instrument failures and lead the RCA in support of investigations.
- Lead the implementation of CAPA's and Change Control Program for GMP systems.
- Comply with and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.
- Conduct and document regular inspections and maintenance of facilities and equipment.
- Oversee installation, operation, maintenance, and repairs to ensure that equipment and instrumentation are installed and functioning according to specifications.
- Support the planning and scheduling of facility shutdowns and projects to meet organizational objectives.
- Periodic travel between our Seattle and Redmond sites for cross training and to ensure coverage redundancy for both locations.
- Associate/bachelor's degree preferred or relevant combination of education and experience.
- Minimum 5-10 years of experience in pharmaceutical facilities maintenance management and experience working in a GMP environment.
- Proficient in the use and administration of Computerized Maintenance Management Systems (CMMS)
- Must be able to lift, push, pull and carry up to 50 lbs; In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet, and body.
- Must have thorough understanding of manufacturing equipment and utilities processes, using P&ID's, equipment manuals, specifications, and Standard Operating Procedures.
- Strong communication skills. Able to effectively lead cross-functional meetings and engage management.
- Able to coordinate and prioritize maintenance related issues with various stakeholders including managers, manufacturing, Facilities and Engineering, QC, supply chain, CMMS, cleaning, and QA personnel.
- Ability to multi-task in a highly dynamic and diverse environment.
- Strong computer skills including Microsoft office.
- Strong Facilities Management background of GMP Pharmaceutical Manufacturing operation
- 5 years of direct or indirect leadership experience
- Experience in GMP audit/inspections is a plus.
The base pay range for this position at commencement of employment is expected to be $90.,000 to $135,000; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
FR : Dans le cadre de sa politique Diversitİ, Evotec İtudie, compİtences İgales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.