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Director Automation - Redmond, United States - Evotec WD
Description
The Director Automation is responsible for leading the Automation Team in Global MSAT.This role is responsible for defining the process control automation system and manufacturing execution system standards for the J.POD Manufacturing platform, ensure alignment across the J.POD network, as well as provide process automation support to Just-Evotec's biologics manufacturing sites.
This individual is expected to have an advanced proficiency and leadership in DeltaV process control automation (SCADA and DCS) as well as PAS-X MES deployment, configuration, and integration to other automation systems.
Experience working in a GMP environment, change control, and automation validation in accordance with GAMP5 guidelines is expected.Responsibilities:
Report to the VP of Global MSAT and leads the Global Automation Team. Responsible for recruitment and employee development in the automation organization.
Lead the design and implementation of new process digital systems, automation and process control schemes to advance the state of the J.
POD continuous manufacturing platformDefine global software development life cycle (SDLC) and global roadmap for DeltaV, MES, and other process digital systems
Partner with Site MSAT Automation teams to lead or support global and site objectives
Define strategy for the development or improvement of detailed specification, qualification (IQ/OQ/PQ), engineering, SOP, and training documents
Collaborate with multiple disciplines, including manufacturing, process engineering, process development, data scientists, utility operations, maintenance, quality assurance, and validation to lead implementation of operational improvements
Provide digital systems project oversight or lead complex implementation projects contracted to 3rd party
suppliers/integrators
Position Requirements:
B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering
15+ years relevant experience in pharmaceutical, biotech, or life sciences
Strong process automation background and experience in design, installation, programming, and validation of automated processes
Understand FDA CFR 21 Part 11 compliance
Established record of leading successful project completions employing proven engineering and project management skills
Demonstrated leader of automation teams
Candidate must possess strong focus on quality and attention to detail
Motivated, self-starter with strong organizational skills
Good interpersonal, team, leadership, and communication skills are a must
Previous experience in computer software validation
Additional Preferred Qualifications:
Lead roles on Global teams, Center of Excellence, etc.
Previous roles as a digital system Business Process Owner
Leverage expertise using GAMP5 risk-based approach when implementing changes to the validated PAS
Authority inspection or audit support involvement
Experience with DeltaV and PAS-X
Working knowledge of biomanufacturing upstream and downstream process operations and process control strategies.
The base pay range for this position at commencement of employment is expected to be
$127,050 - $235,950 ; 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.
Evotec (US) Inc. is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
About Us
Just – Evotec Biologics, wholly owned by Evotec SE, is a first-to-industry biologics platform that leverages AI/ML technologies and world-leading molecular design, cell line development, process intensification and continuous manufacturing strategies to advance biotherapeutics from discovery through clinical stages to commercial launch.
The Just – Evotec Biologics team combines deep industry experience in the fields of data, protein, process, and manufacturing sciences including automation with highly integrated and flexible capabilities to break through the scientific and economic barriers associated with the development of protein therapeutics.
Our focus is to accelerate and expand access to biotherapeutics through scientific and technological innovation for our proprietary projects and on behalf of our partners.
Learn more at.
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