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Process Automation Engineer Cell Therapy information
How does a process automation engineer in cell therapy typically collaborate with cross-functional teams during project execution?
What is the difference between Process Automation Engineer Cell Therapy vs Process Validation Engineer?
| Aspect | Process Automation Engineer Cell Therapy | Process Validation Engineer |
|---|---|---|
| Credentials | Bachelor's in Engineering, Life Sciences, or related field; experience with automation systems | Bachelor's in Engineering, Life Sciences, or related field; experience with validation protocols |
| Work Environment | Biotech manufacturing, cell therapy labs, automation system setup | Manufacturing facilities, quality assurance labs, validation processes |
| Industry Usage | Cell therapy manufacturing companies, biotech firms | Pharmaceutical and biotech manufacturing, quality departments |
The Process Automation Engineer Cell Therapy focuses on designing, implementing, and maintaining automation systems specific to cell therapy production. In contrast, the Process Validation Engineer ensures manufacturing processes meet quality standards through validation protocols. Both roles require a strong understanding of biotech manufacturing, but their core responsibilities differ in automation versus process validation tasks.
What are the key skills and qualifications needed to thrive as a process automation engineer in cell therapy?
What does a process automation engineer in cell therapy do?
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Process Automation Engineer, Manufacturing Engineering
Saint Louis, MO • On-site
Full-time
Posted 21 days ago
Thermo Fisher Scientific rating
7.7
Based on 422 frontline employees who took The Breakroom Quiz
196th of 536 rated manufacturers
Job description
Standard Office Hours (40/wk)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
The Process Automation Engineer is a key member of the site Engineering team, reporting to the Manufacturing Engineering Automation Manager. This role is responsible for supporting and enhancing the site's Operational Technology (OT) infrastructure and automation systems used in GMP manufacturing.
You will provide technical leadership for process control systems, support manufacturing equipment reliability, and lead automation initiatives that improve system performance, data visibility, compliance, and operational efficiency.
This role also supports capital projects, including system design and review, installation, commissioning, qualification (IQ/OQ/PQ), and lifecycle management. Success requires strong technical expertise, cross-functional collaboration, and structured problem-solving in a regulated environment.
What will you do?
- Design, implement, and maintain process control systems in compliance with corporate standards and site GMP requirements.
- Provide technical ownership of DeltaV, PLC, SCADA, and associated automation platforms.
- Lead troubleshooting efforts for control systems, networked devices, and data acquisition platforms.
- Develop and implement system enhancements to improve equipment reliability, throughput, and data integrity.
- Ensure compliance with software lifecycle management, patching strategies, licensing, and cybersecurity standards.
- Support validation documentation including URS, FRS, SDS, IQ/OQ protocols, and change control documentation.
- Integrate manufacturing data sources (PLCs, historians, MES, etc.) to improve operational visibility and reporting.
- Develop monitoring and alerting tools to proactively detect system issues.
- Participate in and support regulatory inspections and audits.
- Collaborate with Corporate IT to maintain secure and compliant OT/IT network integration.
- Provide on-call support for critical manufacturing systems as required.
How will you get here?
- Bachelor's degree in Electrical Engineering, Computer Engineering, Computer Science, or related technical field is highly preferred. Associate Degree or equivalent is required.
- Equivalent combination of education and relevant experience may be considered.
- 2+ years of experience supporting automation systems in a regulated manufacturing environment (pharmaceutical, biotech, medical device preferred).
- Hands-on experience with DCS and PLC platforms (DeltaV, Rockwell, Siemens, etc.).
- Experience with system commissioning, loop tuning, and startup activities.
- Experience supporting GMP change control and validation processes.
Technical Knowledge
- Strong understanding of PLC and DCS programming, including ladder logic and function block programming.
- Knowledge of industrial networking (TCP/IP, VLANs, firewalls, managed switches).
- Experience with data historians, SQL databases, and manufacturing data integration.
- Familiarity with 21 CFR Part 11, data integrity principles, and GMP automation requirements.
- Experience with SCADA system configuration and maintenance.
- Understanding of ISA-88 batch control concepts (preferred).
Behavioral Competencies
- Demonstrated ability to lead technical problem-solving efforts.
- Strong communication and cross-functional collaboration skills.
- Ability to prioritize and manage multiple projects in a fast-paced GMP environment.
- Proactive mindset with focus on continuous improvement.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Other
Relocation assistance is not provided.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
What Thermo Fisher Scientific employees say
Pay
Benefits
Hours and flexibility
Workplace
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About Thermo Fisher Scientific
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
10,000+ Employees
Headquarters location
Waltham, MA, US
Year founded
1956