- Job type
- Full-time
- Work mode
- On-site
- Level
- Not listed
- Department
- Engineering
- Experience
- 3+ years experience
- Posted
- Aug 26, 2026
About the role
Key Responsibilities
Documentation & Compliance
- Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)
- Generate and execute test protocols and scripts
- Ensure adherence to 21 CFR Part 11 and data integrity principles
- Review and contribute to validation plans and risk assessments
System & Industry Expertise
- Support CSV activities across various platforms including MES, DCS, SCADA, and batch systems
- Engage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware
- Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)
- Utilize familiarity with S88/S95 batch control standards
- Apply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell
Client Support & Technical Execution
- Support client engagements with strong customer-service orientation
- Perform system assessments and remediation related to data integrity
- Collaborate with client teams to ensure validation compliance and delivery
Qualifications and Experience
- Bachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted
- Minimum of 3+ years of experience in computer systems validation
- Experience in biotech or pharmaceutical environments preferred over medical device
- In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)
- Familiarity with S88/S95 batch control standards
- Experience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred
- Experience with multiple automation and manufacturing execution systems is highly desirable
- Data integrity assessment/remediation experience is a plus
Other Requirements
- Excellent oral and written communication skills in English
- Ability to travel domestically and internationally as required
- Willingness to work paid overtime when needed
- Must be authorized to work in the U.S. without current or future sponsorship
