Impel Talent is leading a confidential search for a Senior Project Engineer for a globally recognized company in the pharmaceutical manufacturing sector. This international, family-owned company is renowned for its innovative technological capabilities and strong market presence. The company’s success is driven by a dedicated, diverse team of professionals across multiple global locations.
Responsibilities:
• Author, review, and execute CSV documentation including validation plans, protocols, and reports.
• Validate system security, audit trails, access controls, and data integrity functionalities.
• Assess vendor software documentation and perform software risk assessments.
• Work cross-functionally with QA, Engineering, IT/OT, and Automation teams.
• Support system upgrades and changes from a compliance and validation standpoint.
• Contribute to internal policies, SOPs, and templates related to CSV practices.
Qualifications:
• Bachelor’s degree in Engineering, Computer Science, or a related field.
• 5+ years of experience in CSV within GMP-regulated environments.
• In-depth knowledge of GAMP 5, 21 CFR Part 11, and Annex 11.
• Hands-on experience validating SCADA, DCS, MES, or ERP systems.
• Familiarity with systems such as Siemens WinCC, Delta V, or similar platforms.