CSV Engineer

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values.

Responsibilities:

• Collaborate with facility Subject Matter Experts (SMEs) to document user requirements and update application system User Requirements, Functional, and Design Specifications.
• Develop and execute validation documentation, including Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualification (PQ) scripts.
• lead or execute test activities and validation processes according to timelines.
• Route validation documentation and manage tasks under aggressive schedules.
• Work closely with cross-functional project teams and interact professionally with customers at multiple sites.
• Conduct validation of computer systems, process automation, equipment, utility systems, and facilities following SOPs, GMPs, GAMP5, and all regulatory requirements.
• Compile and analyze validation data, prepare reports, and recommend process improvements.
• Coordinate and execute validation change control, including drafting protocols, reports, and data tables.
• Maintain all documentation related to validation processes and assist in developing procedures and/or protocols.

Requirements

Qualifications:

• 3 to 5 years of experience in the pharmaceutical industry, focusing on computer system validation.
• Proven validation experience with enterprise computer systems (ERP, LIMS, QMS, ECM, LMS) within a life sciences manufacturing environment. In-depth knowledge of cGMP, GDP, GAMP, 21 CFR Part 11, and industry best practices.
• Strong technical expertise, with proficiency in MS Word.
• Excellent communication and interpersonal skills to interact effectively with clients, peers, and vendors.
• Ability to work independently, quickly adapt, and adhere to project timelines.
• Demonstrated problem-solving skills, with experience troubleshooting and recommending solutions