Project Manager Validation Services

Sartorius; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sartorius in Bengaluru seeks a Technical Project Manager for Validation Services to drive commercial growth and operational excellence by leading customer validation projects and coordinating cross-functional execution. You will ensure regulatory compliance and timely delivery of validation documents and technical support to customers.

The role involves preparing quotes for test scenarios, tracking leads, and traveling up to 30% for on-site visits and workshops.

Qualifications

• 6–10 years of experience in biochemistry/biotech analytical fields.
• Understanding of GMP and regulatory topics.
• Hands-on knowledge of extractables and leachables with the listed analytical techniques (HPLC, GC-MS, LC-MS, ICP-MS).
• Experience in a similar role is advantageous.
• Familiar with final container stability studies and extractables/leachables is a plus.
• Strong learning ability and expert knowledge base in validation area.
• Excellent communication and presentation skills.

Responsibilities

• Lead customer validation projects and coordinate cross-functional execution.
• Manage customer relationships and ensure regulatory compliance and project success.
• Prepare, review and approve validation documents in English.
• Prepare quotes for different test scopes and track leads via tools.
• Travel up to 30% for on-site customer visits and workshops.
• Support sales targets and collaborate with application specialists for cross-selling.

Skills

Project management

Regulatory knowledge

Biochemistry background

Communication

MS Office

Education

Bachelor's degree in Biochemistry/ Biotechnology

Tools

HPLC

GC-MS

LC-MS

ICP-MS

Job description

The Technical Project Manager, Validation Services

The Technical Project Manager, Validation Services drives commercial growth and operational excellence by leading customer validation projects, managing customer relationships, and coordinating cross-functional execution to ensure regulatory compliance, customer satisfaction, and business success. Coordination of validation projects on behalf of customers in a timely manner according to the agreed test scenario as well as in compliance with regulatory requirements (e.g. FDA, EMA, WHO). Provide technical consultancy and risk assessment based on Sartorius Stedim validation philosophy and globally harmonized test methods. Preparation, review and approval of scientific and technical validation documents (statements, protocols, reports and other documents) in English. Preparation of quotes for different test scenarios / scopes. Track all validation leads and projects via applicable tools and provide monthly summary report. Be responsible for the assigned targets to support sales target achievement in the defined territory. Provide technical support proactively, answer inquiries and resolve implementation problems in the field for customers. Provide basic technical training to internal sales and dealers, and running external customer workshops and seminars. Support the consumables business growth via cooperation with application specialists for cross selling. Role requires minimum of 30% travel with onsite customer and sales visits (e.g. acquiring new projects, presentation of Validation Services, generating validation leads).

Qualification & Skills:

• Min of 6 - 10 years experience with academic degree in Biochemistry, biotechnology or other related analytical fields
• Understanding on GMP and regulatory topics
• Hands-on knowledge on extractable and leachables with related analytical techniques like HPLC, GC-MS, LC-MS, ICP-MS is a must.
• Proven experience in a similar position and industry is advantageous
• Familiar with final container stability studies and extractable & Leachables is a plus
• Strong learning ability, and expert knowledge base in this area
• Ability to effectively interface with product / project / division management
• Excellent communication and presentation skills
• Strong customer orientation
• Proven software skills, e.g. Microsoft Office
• Fluent in English and ideally in other local languages

About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide. We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment. Join our global team and become part of the solution.