Verantwoordelijk voor project engineering activiteiten rond fillingequipment (filling lines, isolators, e-beams, washers, tunnels en/of cappers).
Technische input leveren binnen projectteams, met focus op installatie, technologie of procesimplementatie.
Opstellen en reviewen van technische specificaties (EDS, P&ID’s, elektrische schema’s) samen met SME’s.
Toepassen van engineering standaarden en afstemmen met de lead engineer tijdens design, constructie en implementatie.
Opvolgen van constructie, installatie en functioneren van het equipment om conformiteit met de specificaties te garanderen.
Toepassen van project management best practices: planning, budgetcontrole, issue- en risicomanagement, rapportering en stakeholdermanagement.
Toezicht houden op externe contractors voor constructie, installatie of testing.
Verantwoordelijk voor overdracht naar operations, inclusief volledige projectdocumentatie en project close-out.
Opvolgen van start-up resultaten en garanderen dat de deliverables behaald zijn.
Correcte documentatie van constructie, verificatie en validatie in het projectdossier verzekeren.
Opstellen en uitvoeren van engineering tests, verificatie- en validatieprotocollen.
Coördineren van goedkeuringen met SME’s en system owners.
Anomalieën onderzoeken en oplossen (deviations, CAPA’s, risk assessments) en zorgen voor cGMP-conforme documentatie.
Profiel
Master of Bachelor in engineering of gelijkwaardig door ervaring.
Ervaring met fillingequipment of procesinstallaties in farmaceutische productie (steriele omgeving is een plus).
Ervaring met testing, verificatie en validatie van equipment.
Sterke technische en operationele kennis van installaties en compliancevereisten.
Ervaring met het opstellen van technische specificaties en projectdocumentatie.
Bekend met cGMP en kwaliteitsprocessen.
Ervaring met projectmanagement (planning, budget, stakeholders).
Hands-on mentaliteit en oog voor detail.
Sterke communicatieve vaardigheden in Nederlands en Engels.
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Scientist – Advanced Material Characterization and Investigations (AMCI) Contracting – Antwerp
Job Description As a Scientist, you will be part of the Advanced Material Characterization and Investigations (AMCI) group within the Analytical Development department. You will work in an international team of experts focused on advanced analytical characterization of pharmaceutical products and conducting analytical investigations within a global R&D context. You will join the Advanced Molecular Analysis (AMA) team, which specializes in structure elucidation using high-resolution mass spectrometry (HRMS), trace analysis, polymer characterization, and the analysis of complex molecules such as peptides and oligonucleotides. We are looking for a motivated chemist with experience in nitrosamine analysis. You will develop and implement innovative analytical methods, with a strong focus on chromatography and mass spectrometry.
Your Responsibilities
Develop and optimize analytical methods for the quantification of nitrosamines in pharmaceutical products, in compliance with applicable guidelines and quality standards
Perform in-depth root cause analyses with a focus on chemical reactivity
Collaborate closely with internal experts and multidisciplinary teams
Initiate and maintain collaborations with universities and research institutions
Ensure a safe working environment in accordance with EHS, GMP, and other regulatory requirements
Your Profile Education and Experience
PhD in analytical or organic chemistry, or a master’s degree with at least 6 years of relevant experience
Experience with nitrosamine determination is a strong asset
Solid expertise in mass spectrometry (Triple Quad, HRMS) is required
Familiarity with chromatographic method development is preferred
Knowledge of GMP and regulatory guidelines (ICH, EMA, FDA) is a plus
Fluent in English, both spoken and written
Personal Competencies
Eager to learn, scientifically curious, and able to work independently
Proactive and creative mindset
Strong collaboration skills in an international team environment
Result-oriented and detail-focused
Flexible, stress-resistant, and with a strong sense of responsibility
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical skills and soft skills. We are your career partner every step of the way. Are you interested in this position? Send an email to [email protected]. We warmly invite you to apply.
