Senior CSV & Automation Engineer
Stark Pharma Solutions Inc
Hi,
My name is Karthik Mutyala, from Stark Pharma Solutions Inc, we are hiring talents for our client. I am working on Sr CSV & Automation Engineer position right now. Please send me your updated resume if you have relevant experience and interested in this position. The detailed job description is as follows.
Role: Senior CSV & Automation Engineer
Location: Thousand Oaks, CA
Duration: Long Term
Position Summary
We are seeking a Senior CSV & Automation Engineer to support automation systems, commissioning, qualification, and validation activities within a GMP-regulated pharmaceutical/biotech environment. The ideal candidate will have strong experience with industrial automation, CSV/CSA, GMP compliance, and control systems implementation.
Key Responsibilities
- Lead startup, commissioning, and qualification of automated equipment, process systems, and utilities.
- Support automation troubleshooting, deviations, CAPAs, and change controls.
- Develop and review validation documentation including URS, FS, DS, IQ/OQ/PQ, risk assessments, and traceability matrices.
- Review vendor documentation and ensure compliance with validation and automation requirements.
- Support lifecycle management of computerized systems and automation platforms.
- Collaborate with Engineering, Manufacturing, Quality, and Validation teams.
Qualifications
- Bachelor s degree in Engineering, Computer Science, Electrical, Mechanical, or related field.
- 7+ years of automation/controls experience and 5+ years in pharmaceutical or biotech GMP environments.
- Strong knowledge of CSV/CSA, GAMP, ASTM E2500, 21 CFR Part 11, Annex 11, and Data Integrity requirements.
- Experience with PLC, HMI, and SCADA systems including DeltaV, Rockwell, Siemens, Honeywell, and FactoryTalk.
- Proven experience supporting commissioning, qualification, and validation projects.
- Strong communication and problem-solving skills.
I am actively connecting with professionals for current and upcoming opportunities. If you are open to exploring new roles or would like to stay informed about relevant positions, please send me your updated resume along with the best number and time to reach you.
Please follow Stark Pharma Solutions on LinkedIn for the latest job updates:
Thank you,
Karthik Mutyala
Recruiting Manager
Stark Pharma Solutions Inc
Email: ***email_hidden***
15 Corporate Place S, Suite 350,
Piscataway, New Jersey 08854
Vacancy posted 4 days ago
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