Manager - Extractable & Leachable Validation services

Sartorius; Bengaluru; Vor Ort; INR 900.000 - 1.500.000; Vollzeit

Zusammenfassung

Sartorius Bengaluru seeks a validation services professional to coordinate customer validation projects in line with regulatory requirements (FDA/EMA/WHO) and Sartorius Stedim philosophy. Prepare and review technical documents in English and provide quotes for test scenarios.

The role involves 30% travel, supporting sales targets in the territory, offering technical training, and liaising with customers and internal teams to drive cross-selling in consumables.

Qualifikationen

• 6–10 years of relevant experience with degree in Biochemistry/ Biotechnology or related field.
• GMP and regulatory topics understanding.
• Hands-on experience with extractable and leachable analyses.
• Experience in validation projects and technical documentation.

Aufgaben

• Coordinate validation projects for customers in line with test scenarios and regulatory requirements.
• Provide technical consultancy and risk assessment per Sartorius validation philosophy.
• Prepare, review and approve scientific and technical validation documents in English.
• Prepare quotes for different test scenarios.
• Track validation leads and projects and report monthly.
• Support sales targets in the defined territory.
• Provide technical support and resolve implementation issues in the field.
• Provide basic training to internal teams and run external workshops.
• Support consumables growth with application specialists for cross-selling.
• Travel 30% for onsite customer and sales visits.

Kenntnisse

GMP & regulatory knowledge

Communication

Customer orientation

English fluency

Presentation skills

Microsoft Office

Ausbildung

Bachelor's degree in Biochemistry/ Biotechnology or related analytical field

Tools

HPLC

GC-MS

LC-MS

ICP-MS

Jobbeschreibung

Job Responsibilities:

• 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 leachable 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 & Leachable 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