PDS Product&Process Change Control Specialist

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join our team at Thermo Fisher Scientific as a Manufacturing Sciences Scientist I where youll contribute to our mission of enabling customers to make the world healthier cleaner and this role youll support manufacturing operations by developing optimizing and implementing production processes while ensuring compliance with quality standards. Youll collaborate with cross-functional teams to manufacture critical products for diagnostics research and therapeutic applications. The position offers opportunities to enhance processes solve technical challenges and directly impact patient care through high-quality manufacturing.

REQUIREMENTS:

Bachelors degree in a scientific discipline (e.g. Chemistry Biochemistry Chemical Engineering Biotechnology) or related field

Proven experience in Change Control management within a GMP-regulated environment preferably in Product & Process Development

Expertise in drafting reviewing and managing Change Controls related to manufacturing processes for clinical (Phase I II III) and commercial products

Experience with sterile products including liquid and lyophilized formulations in vials and pre-filled syringes

Basic knowledge of manufacturing processes and process development activities

Good knowledge of GMP and GDP requirements

Hands-on experience with electronic Quality Management Systems preferably TrackWise

Ability to perform impact and risk assessments and ensure timely progression of Change Controls

Strong organizational skills with the ability to manage multiple activities and priorities

Strong communication and collaboration skills with the ability to effectively interact with cross-functional teams

Fluent in English; additional languages are a plus

COLLABORATION & INTERFACES:

The role will be part of the Product & Process Development team at the PDS site in Monza

Close collaboration with Process Scientists and Master Batch Record teams to support Change Control definition and execution

Active interaction with cross-functional stakeholders including QA QC Manufacturing and MSAT to ensure proper assessment alignment and timely closure of Change Controls