Director, Capital Projects
Just-Evotec Biologics is seeking a highly motivated Director of Capital Projects that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to lead the design, construction and validation of capital projects related to GMP biologics manufacturing and quality control & process development laboratories at Just-Evotec Biologics’ state of the art facilities in Seattle and Redmond, WA. This position 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.
Typical project responsibilities will entail design and construction of modifications and additions to our J.POD™ facility and its associated production and quality systems. Retrofitting and expanding our laboratory and office facilities are other planned activities. Additional manufacturing projects may include (allogeneic) cell therapy and clinical scale fill/finish.
- Bachelor’s degree in Engineering or related science with 10+ years relevant experience; Equivalent work experience and service may be considered
- Demonstrated experience delivering capital projects in the biopharmaceutical sector.
- Experienced in leading all aspects of capital projects, including budgeting, design, construction, commissioning, and validation.
- Proven leadership and construction project management skills and ability to negotiate issues with both tact and practicality
- 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, development of user requirement specifications, implementation of design, installation, operation, and performance qualifications, and validation summary reports
- Previous experience managing the activities of individuals, work groups, and project teams.
- Candidate must possess strong focus on quality and attention to detail
- 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
Additional Preferred Qualifications:
- Working knowledge of US FDA CFRs and European EMA, including ICH guidelines
- In-depth knowledge of equipment, operations, and engineering principles
- Operational engineering experience and knowledge of building systems including mechanical, electrical and plumbing (MEP), HVAC, fire/life safety, and waste management.
- Working knowledge of Quality Assurance standards, including risk assessments
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 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 250+ employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in Redmond, WA.