Senior Automation Engineer, Digital Solutions Site MSAT

Sr. Automation/Process Control Engineer – Site MSAT

Just-Evotec Biologics is seeking a motivated Sr. Automation Engineer, PCS that desires a significant opportunity to improve worldwide access to biotherapeutics. Process automation is a cornerstone of Just’s manufacturing technology. This role is part of the Automation team in Site MSAT that is responsible for maintaining automation (DeltaV) recipes for the J.POD Manufacturing platform and working with the global MSAT team to ensure alignment across the J.POD network, as well as provide automation support to Just-Evotec’s manufacturing sites. This includes designing and implementing creative solutions to complex technical challenges in helping Just achieve a novel flexible and reconfigurable cGMP manufacturing facility focused on continuous processing. The successful candidate will have an advanced proficiency of DeltaV process control automation (SCADA, DCS) and beginner level proficiency in MES (Manufacturing Execution Systems) used for bioprocessing control as well as at least some experience in other automation platforms (ie, Siemens, Allen-Bradley, Wonderware, etc.). Experience working in a GMP environment, change control, and automation validation in accordance with GAMP5 guidelines is highly preferred.

Responsibilities (including but are not limited to):

• Participate in the design and implementation of automation and process control schemes to NPI processes, batch tracking, establishing process control limits, and applying predictive control algorithms.
• Maintain site level validated DeltaV library and participate at the site level governance and change management system for GMP changes and NPI implementation
• Participate in engagement with global MSAT Automation teams to support global and site objectives
• Develop or improve 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 implement operational improvements
• Author and execute test scripts or validation protocols
• Lead or contribute to technical root cause analysis, incident investigations, and troubleshooting of process control issues.
• Lead CAPAs and change controls, and work closely with the site MTS (Manufacturing technical services) team to implement changes
• Participate as a core team member on the NPI team to ensure all the automation changes/ MES changes are designed/tested as part of NPI readiness.
• Provide technical support to the manufacturing sites as needed, specific to process control and automation systems

Position Requirements:

• B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
• 8+ years relevant experience in pharmaceutical, biotech, or life sciences
• Strong control system automation background. Design, installation, programming, and validation of automated processes is essential.
• Understanding of FDA CFR 21 Part 11 compliance
• Established record of successful project completions employing proven engineering and project management skills
• Demonstrated skills coding in DeltaV
• Demonstrated skills in designed batch records in PASX
• Candidate must possess strong focus on quality and attention to detail
• Motivated, self-starter with strong organizational skills
• Good interpersonal, team, and communication skills are a must
• Excellent oral and written communication skills

Additional Preferred Qualifications:

• Previous experience in computer software validation
• Participation on global teams, Center of Excellence, etc.
• Leverage expertise using GAMP5 risk-based approach when implementing changes to the validated PAS
• Authority inspection or audit support involvement
• Experience with single-use technologies and systems
• Experience with Siemens, Allen Bradley, Wonderware automation platforms

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job.  It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $111,360 to $152,425;  Base salary offered may vary depending on the 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.