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
Critical Competencies
Influence Strategy
- Pursues opportunities based on organizational fit and strategy
- Identifies high-impact, innovative solutions
Satisfy the Customer
- Anticipates and meets client needs
- Delivers high-quality solutions and maintains satisfaction
Plan for Success
- Aligns business goals with execution plans
- Allocates resources and builds risk mitigation strategies
Pursue Execution
- Prioritizes effectively and ensures accountability
- Proactively addresses challenges
Tailor Communication
- Communicates clearly and professionally
- Adapts style for technical and non-technical audiences
Build Partnerships
- Builds cross-functional networks
- Promotes collaboration and stakeholder engagement
Influence Others
- Gains support through sound reasoning
- Promotes innovation and value
Develop Self and Others
- Demonstrates integrity and commitment to growth
- Builds effective relationships internally and externally
#LI-MV1
$75,000 - $106,000 a year
Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.
CAI Benefits:
• Comprehensive Health Insurance coverage
• 24 days of Paid Time Off
• Company paid Life Insurance
• Company paid Long Term Disability
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
