Senior Automation Engineer Digital Solutions Site MSAT
Senior Automation Engineer Digital Solutions Site MSAT
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Job Description
Sr. Automation/Process Control Engineer Site MSAT
JustEvotec 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 Justs 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 JustEvotecs 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 Systems) used for bioprocessing control as well as at least some experience in other automation platforms (ie Siemens AllenBradley 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 selfstarter 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 riskbased approach when implementing changes to the validated PAS
- Authority inspection or audit support involvement
- Experience with singleuse 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 JustEvotec 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 $111360 to $152425; Base salary offered may vary depending on the individuals skills experience and competitive market value. Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision shortterm and longterm 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.
Required Experience:
Senior IC
Employment Type
Full-Time
