This is Srikanth from Reliable Software. We have an opportunity with one of our direct clients, and I'd like to share the details with you. Please review the information below and let me know if you're interested. Kindly share your updated resume if you'd like to be considered.
Job Title: Validation Engineer II – CSV & Compliance
Location: Hillsboro, OR (Hybrid onsite)
Role Summary
The Validation Engineer II – CSV & Compliance supports IT and OT system owners by ensuring GMP-regulated manufacturing systems remain compliant throughout their lifecycle. This role focuses on Computer System Validation (CSV), documentation, compliance reporting, and ongoing system maintenance for ISA-95 Level 2 and Level 3 systems within regulated manufacturing environments.
Required Skills & Qualifications
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field.
- 3–6 years of experience in Computer System Validation within a GMP-regulated environment.
- Strong understanding of CSV lifecycle management for manufacturing systems at ISA-95 Level 2 and Level 3.
- Experience with regulatory standards such as FDA cGMP, GAMP 5, and 21 CFR Part 11.
- Familiarity with manufacturing systems such as MES, SCADA, PLCs, historians, or automation systems.
- Experience supporting audits and compliance inspections.
- Strong documentation, analytical, and problem-solving skills.
- Ability to work cross-functionally with IT, Quality, Engineering, and Operations teams.
Preferred Qualifications
- Experience with IT/OT system integration in regulated manufacturing environments.
- Knowledge of data integrity principles (ALCOA+).
- Exposure to cloud-based or hybrid manufacturing systems.
- Prior experience in pharmaceutical, biotech, or medical device industries.
Educational Qualifications:
- Required - Bachelor’s degree in Computer Science, Information Technology, Computer Engineering or closely related or equivalent.
- Preferred - Master’s degree in Management Information Systems (MIS), Computer Science, Big Data or Analytics or equivalent.
Travel:
· Open to travel based up on the nature of the engagement.
Thanks & Regards
Srikanth Donkani
Sr. Talent Acquisition Specialist
(w):
(E):
2260 Haggerty Road, Suite 285 Northville, MI 48167
Equal Employment Opportunity
Reliable Software employment does not discriminate on the basis of race, religion, gender, sexual orientation, age or any other basis as covered by federal, state, or local law.
Employment decisions are based solely on qualifications, merit and business needs.
Never miss an opportunity! Create an alert based on the job you applied for.
