Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Are you ready to join a dynamic team with diverse skills and make a significant impact?

Join us as we strive for excellence in Sterility Assurance!

You'll work closely with the Sterility Assurance Manager to ensure sterile drug manufacturing meets cGMP standards.

Define and maintain Contamination Control Strategy, collaborate with site functions to uphold aseptic standards.

Main responsibilities

Defines, supervises, and contributes to the continuous improvement of the site Environmental Monitoring (EM) program, coordinating its long-term efficiency.Coordinates and supervises the Media Fill program.Supervises the application of Good Manufacturing Practices (GMP) related to aseptic behavior, facilitating their implementation through dedicated training.Coordinates and supervises sterilization processes.Collaborates with site functions in drafting and/or revising risk assessments aimed at identifying and evaluating potential gaps in production processes and utilities.Evaluate investigations affecting sterility assurance in manufacturing areas, participate in defining corrective actions.Supports the review and acts as a backup approver for Major/Critical Deviations and any Change Proposals impacting Sterility Assurance.Receives ongoing GMP training related to sterility assurance and transfers such training to site SMEs.Supports the Sterility Assurance Lead/Manager as the site SME for aseptic topics during regulatory and/or customer audits.Supports the Sterility Assurance Lead/Manager as an SME in sterility assurance evaluations for new product introductions and new projects (e.g., new lines/processes).Engages in assessing compliance with current regulations and future updates, implementing standard processes.

This position seeks a curious and ambitious professional with the motivation and interpersonal skills to excel in a dynamic environment. We are dedicated to equal opportunities and encourage applications from all qualified candidates.

Requirements

Degree in Biology or other scientific fields (Chemistry, CTF, Biotechnology)Proven experience in a similar position within a regulated environment such as pharmaceuticals and/or biotech.Expertise in GMP regulations (EU and US).In-depth knowledge of sterile injectable drug production processes.

Knowledge, Skills, Abilities

Consolidated knowledge of production plants and manufacturing techniques in asepsis/terminal sterilizationStrong understanding of sterile product manufacturing and good aseptic practicesPrinciples of Quality Risk Management

Join us and make a difference! Apply now to be part of a team that values innovation and quality.