Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you’ll 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 world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION: Responsible for project engineering activities related to process development and process equipment basic to detailed design
Join call/meeting with clients to provide technical information and collect all process requirements (URs)
Provide technical input in the project team for own discipline, having technical and operational knowledge and expertise. Know how process development and know the internal requirements (operational/technical/compliance).
Define and documents the technical specs (Design specifications, P&ID’s, layouts, functional specifications, ecc.) and review with the relevant SME.
Follow the Good Engineering Practice (GEP)
Follow up the construction and implementation activities to guarantee the installation is according to spec.
Guarantee good PM practices and tools (schedule, budget control, issues, decisions, reporting, stakeholder management, …).
Keep oversight of the contractor company that will build, install or test the equipment.
Deliver all project documentation and close out of the project. Follow start up results to guarantee that the project deliverables were achieved.
Deliver all projects within cost and timeline according to business strategies.
PE is responsible to manage changes and document actions (CAPA’s, risk assessments, CGMP review, new document versions).
Qualifications
Master's Degree (mechanical/chemical engineering)
3+ years of experience
Knowledge of Good Manufacturing and Engineering Practice (GMP, GEP) and experience in Pharmaceutical environment
Experience of project orientated admin/cost control/management
Previous experience in API/Chemical manufacturing companies, Engineering Companies in similar roles (Project or Process Engineering for Pharma applications)
Strong technical, management and organizational skills
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