- 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 platform
- Define 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
- 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
- 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.
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Director Automation - Redmond, United States - Evotec
Description
Director Automation- Global MSATThe 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:
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.
