CSV/CSA Engineer

Job not on LinkedIn

🕒 February 10

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

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Pharmatek

WebsiteLinkedInAll Job Openings

11 - 50 employees

💊 Pharmaceuticals

🤝 B2B

Pharmaceuticals • B2B

Pharmatek is a consulting firm specializing in serving pharmaceutical and life sciences companies with IT, business, and engineering consulting services. The company focuses on aligning people, technology, and business processes—offering expertise in manufacturing, laboratory, and process engineering as well as IT and business lifecycle disciplines. With around 20 years of industry experience, Pharmatek provides nationwide resourcing and subject-matter experts to pharmaceutical and life sciences clients.

📋 Description

• Execute CSA and validation activities in accordance with SDLC procedures and quality expectations • Assist in preparation of validation plans, functional risk assessments, and traceability matrices • Support review of validation/testing documentation and change control artifacts • Contribute to validation summary reporting and lifecycle compliance deliverables • Provide support for CMDB management and validation tool usage as needed • Collaborate with Digital Quality, System Owners, and Business stakeholders throughout execution

🎯 Requirements

• 4–5+ years in CSV/CSA or regulated system validation support • Working knowledge of validation lifecycle documentation and SDLC processes • Experience reviewing test artifacts, requirements traceability, and change controls • Ability to operate effectively in a remote, globally distributed team • Preferred exposure to SAP or enterprise platform validation • Preferred familiarity with GxP documentation practices and ALCOA+ principles • Preferred experience supporting validation execution within life sciences

🏖️ Benefits

• Remote work