Pharma Documentation Engineer - Validation & Documentation
- Location
- Navi Mumbai, Maharashtra, India
- Salary
- Not specified
- Company
- Akash pawar
Job description
• Role & Company / Project Overview: Aquamech Engineering Corporation is seeking a Pharma Documentation Engineer - Validation & Documentation for pharmaceutical utility and high-purity water systems, based in Navi Mumbai. • Key Responsibilities & Daily Duties: - Prepare, review, and maintain comprehensive validation documentation for Purified Water (PW), Water for Injection (WFI), Highly Purified Water (HPW), Ultra Pure Water (UPW), and RO EDI systems. - Ensure all validation protocols, reports, and documentation strictly comply with cGMP, ASME BPE, and USFDA regulatory standards. - Collaborate with engineering and project site teams regarding documentation requirements for pharmaceutical utilities. - Review technical specifications, qualification documents (DQ, IQ, OQ, PQ), and system manuals. • Required Qualifications, Skills & Experience: - 3 to 10 years (3–7 years) of experience in validation and documentation within pharma utility or high-purity water systems. - In-depth hands-on experience with pharma water system validation in engineering, EPC, or manufacturing environments. - Solid working knowledge of cGMP, ASME BPE, and USFDA compliance guidelines. • Working Hours, Shifts & Location Details: - Job Type: Full-Time. - Location: Navi Mumbai, Maharashtra, India. - Workplace Type: Office Based. • Compensation & Benefits: - Not specified. • Application Instructions: - Mention the job role in your application and forward your CV to the HR email address.