Director/Senior Director, Facilities & Engineering | Seattle & Redmond WA
Just-Evotec Biologics is seeking a highly motivated Director/Senior Director of Facilities & Engineering that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to lead and guide the Facilities & Engineering (F&E) functions for both GMP Biologics Manufacturing and QC laboratories and Process Development Laboratories at Just-Evotec Biologics state of the art J.POD™ Facility, located in Redmond WA, as well as Just-Evotec Biologics Clinical Production Facility, located in in the South Lake Union neighborhood in Seattle, WA. This highly qualified candidate will partner with Manufacturing Operations, Technical Operations, Quality Assurance, Quality Control, Materials Management, Process Development and EH&S functions to ensure regulatory compliance and optimal functioning of all manufacturing, laboratory, and building spaces.
The primary job responsibilities include completing the design, build, and validation the J.POD™ Facility and associated production/quality systems; ensuring that these are suitable for phase 3 manufacturing, pre-positioned to be commercially compliant, inspection ready, and licensable by US FDA and EMA health authorities.
Additional F&E responsibilities for GMP biologics manufacturing sites will be to maintain both biologics facilities in a state of control for cGMP operations. This includes the implementation and maintenance of: SOP(s) and documented procedures for facility and equipment maintenance; Computerized maintenance management system; Equipment and utilities preventative maintenance; Metrology program; Spare parts inventory; Clean utilities systems; Black utilities systems; HVAC and clean room systems; Electrical systems (including UPS and standby power); Lights and lighting controls; Deviations, change control, and other facility/equipment related investigations; Cell bank storage systems; Janitorial clean room services; Pest control; Waste water and solid waste handling; and Security/access control;
F&E responsibilities for the Process Development laboratories, offices, and building operations include, but are not limited to: Managing and scheduling preventative maintenance and calibration of air handling units, autoclave(s), glass washer, biological safety cabinets, purified water system, and building automation system; Overseeing and scheduling shutdown planning, equipment upgrades, and facility repairs; Deliver on a commitment to laboratory safety including inspections and audits; Develop and implement an engineering and maintenance strategy for each site; Lead space planning activities; Lead vendors to deliver projects on time and on budget; and Oversee janitorial and maintenance services.
- Bachelor’s degree in Engineering or related science with 10+ years relevant experience; Equivalent work experience and service may be considered
- Extensive experience in cGMP biopharmaceutical regulated environment including technical understanding of GMP dedicated utilities systems
- Strong knowledge of biologics manufacturing equipment and utilities systems, including but not limited to HVAC, WFI, pure steam, clean compressed air, process gases, chilled water, boilers, and wastewater treatment
- Plant utilities commissioning, qualification, and validation experience, including risk assessments, user requirement specifications, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reports
- Substantial operational engineering experience and knowledge of building systems including mechanical, engineering and plumbing (MEP), HVAC, fire/life safety, and waste management.
- Subject matter expert representing and defending GMP systems in audit settings
- Experienced in the use of electronic systems such as QMS and CMMS.
- Previous experience managing the activities of individuals, work groups, and project teams.
- Candidate must possess strong focus on quality and attention to detail
- Possess effective task/time management organizational skills
- Motivated, self-starter with strong mechanical aptitude
- Good interpersonal, team, and communication skills are a must
- Excellent oral and written communication skills
- Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)
Additional Preferred Qualifications:
- Thorough working knowledge of US FDA CFRs and European EMA, including ICH guidelines
- In-depth knowledge of equipment, operations, and engineering principles
- Working knowledge of Quality Assurance standards, including risk assessments
- Experienced in leading all aspects of capital projects, including budgeting, design, construction, commissioning, and validation.
- Proven leadership and lab construction project management skills and ability to negotiate issues with both tact and practicality
About Just – Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood – the center of Seattle’s medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers
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