Validation Services Project Manager – Sartorius

Are you ready to step into a dynamic role as a Validation Services Project Manager? Sartorius, a global leader in the biopharmaceutical industry, is seeking a highly skilled professional to join their team in Bangalore, India. This full-time, regular position gives you the unique opportunity to work at the absolute forefront of medical and scientific innovation. As a key member of the sales and technical operations team, the chosen candidate will drive commercial growth and operational excellence. Let’s explore what this role entails.

Responsibilities

1. Project Coordination: Oversee and execute multi-faceted validation projects on behalf of regional and international clients. You will ensure everything is completed within agreed-upon timelines and strictly satisfies regulatory guidelines established by bodies such as the FDA and EMA.

2. Technical Consultancy: Deliver authoritative risk assessments and consulting based on the globally harmonized Sartorius Stedim validation philosophy.

3. Documentation Management: Take ownership of preparing, reviewing, and approving critical scientific documentation, technical reports, and statements in English.

4. Commercial Support: Draft quotes for varying test scenarios and project scopes. Cooperate closely with the application specialists to drive cross-selling and support consumables business growth.

5. Client Engagement: This position requires a minimum of 30% travel to conduct onsite customer and sales visits, acquire new projects, and generate validation leads.

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Qualifications

1. Education & Experience: An academic degree in Biochemistry, Biotechnology, or a related analytical field, paired with 6 to 10 years of proven industry experience.

2. Technical Knowledge: Hands-on experience with extractables and leachables (E&L) analysis is a strict requirement. Proficiency in advanced analytical techniques such as HPLC, GC-MS, LC-MS, and ICP-MS is crucial.

3. Regulatory Familiarity: Deep comprehension of Good Manufacturing Practices (GMP) and final container stability studies.

4. Soft Skills: Outstanding communication and presentation skills are required to seamlessly interface with internal product, project, and division management teams.