Pharmaceutical Packaging and Process Engineer
De functie
De Pharmaceutical Packaging and Process Engineer levert technologische expertise aan de productieafdelingen van Organon Oss. Dit omvat het overdragen van nieuwe producten en processen, het introduceren van verpakkings- en procestechnologieën, het kwalificeren van apparatuur en het onderhouden van producten, processen en technologieën. De functie kan ook ondersteuning bieden aan andere Organon-locaties of aan gelieerde contractfabrikanten.
Daarnaast is de Pharmaceutical Packaging and Process E ngineer verantwoordelijk voor het opzetten, onderhouden en werken binnen systemen zoals het Organon Quality Management System (QMS), SHE-systemen, risicobeheer, afwijkingenbeheer, change control en SAP.
Welkom in het team
De functie van Pharmaceutical Packaging and Process Engineer valt binnen het CoE Pharmaceutical Technical Operations (PTOi) van Organon Oss. De functie rapporteert aan de sectieleider Packaging. PTOi Oss bestaat uit de secties Solids, Steriles, Polymerics en Packaging. De engineer werkt zowel in lokale als internationale projectteams en combineert technische verantwoordelijkheden met projectmatige, coördinerende en soms leidinggevende taken. Binnen deze teams is er nauwe samenwerking met diverse afdelingen zoals Operations, Quality, Regulatory, Procurement, Supply, Facility Management, Engineering en PTOi.
Verantwoordelijkheden
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Het verwerven en behouden van technologische kennis met betrekking tot producten, processen, apparatuur en bijbehorende leveranciers.
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Het opzetten, coördineren, uitvoeren en rapporteren van onderzoeken ten behoeve van fact findings, (significante) onderzoeken, root cause analyses, tech transfers, CAPEX-projecten, validaties, wijzigingen of verbeteringen.
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Leiden of deelnemen aan projectteams voor fact findings, (significante) onderzoeken, root cause analyses, tech transfers, CAPEX-projecten, validaties, wijzigingen of verbeteringen.
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De taken binnen projectteams zijn divers en kunnen onder andere de volgende kernresultaten omvatten: validatie- en engineeringprotocollen, validatie- en engineeringrapporten, (project)plannen, risicoanalyses, wijzigingen, URS, VMP & kwalificatieprotocollen en -rapporten.
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Deelnemen aan of leiden van peer groups rondom specifieke kennisgebieden.
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Het opzetten, onderhouden en werken met systemen zoals het Organon Quality Management System (QMS), SHE-systemen, change control en SAP. Het verbeteren van processen, producten, technologieën en systemen.
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De betreffende persoon is verantwoordelijk voor het implementeren van het bedrijfsbeleid op het gebied van GMP en SHE. Dit betekent in ieder geval het waarborgen van voorwaarden die collega’s en het team in staat stellen om tijdens hun werkzaamheden te voldoen aan de relevante wet- en regelgeving en bedrijfsregels met betrekking tot GMP en SHE.
Vereiste opleiding, ervaring en vaardigheden
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HBO werk- en denkniveau met een opleiding op het gebied van chemische technologie, werktuigbouwkunde of een andere relevante richting;
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Enige jaren relevante werkervaring in de farmaceutische industrie of een vergelijkbare multidisciplinaire omgeving;
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Sterk technisch en technologisch georienteerd;
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Ervaring met het opstellen van protocollen, uitvoeren en rapporteren van apparatuur kwalificaties, proces- en schoonmaalvalidaties;
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Kennis van primaire, secundaire en tertiare verpakkingstechnieken en verpakkingsmaterialen
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Kennis van GMP-eisen, EHS-richtlijnen en Lean-principes;
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Je weet overzicht te behouden, bent communicatief en kunt anderen enthousiasmeren;
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Je bent overtuigend, kritisch, resultaatgericht, flexibel en je neemt initiatief;
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Goede mondelinge en schriftelijke vaardigheden in Nederlands en Engels.
Wij bieden:
Werken bij ons betekent samen werken aan gezondheid in een internationale werkomgeving met toegewijde collega’s. Je krijgt alle ruimte om jezelf te ontwikkelen en te laten zien wie jij bent. Verder kan je rekenen op aantrekkelijke arbeidsvoorwaarden:
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Een competitief salaris;
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35,5 vakantiedagen;
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8% vakantietoeslag en 3% eindejaarsuitkering;
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Incentive Plan;
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Een uitstekend pensioen;
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Reiskostenvergoeding;
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Ouderschapsverlof voor beide ouders;
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Verschillende trainingsmodules.
Interesse?
Voel jij je aangesproken door deze functie? We nodigen je graag uit om te solliciteren. Laat ons zien wie je bent en hoe jij met jouw vaardigheden en ervaring ons team kunt versterken. We kijken uit naar je reactie!
Secondary Job Description
Pharmaceutical Packaging and Process Engineer
Purpose of the role
The Pharmaceutical Packaging and Process Engineer provide technological expertise to the production departments at Organon Oss. This includes transferring new products and processes, introducing packaging and process technologies, qualifying equipment, and maintaining products, processes, and technologies. The role may also support other Organon sites or affiliated Contract Manufacturing Organizations. Additionally, the Pharmaceutical Packaging and Process Engineer is responsible for setting up, maintaining, and working within systems such as Organon’s Quality Management System (QMS), SHE systems, risk management, deviation management, change control, and SAP.
Welcome to the team
The Pharmaceutical Packaging and Process Engineer function is within CoE Pharmaceutical Technical Operations (PTOi) of Organon Oss. The function reports to the section lead Packaging. PTOi Oss consists of the sections Solids, Steriles, Polymerics and Packaging. The engineer works in both local and international project teams, combining technical responsibilities with project-based, managerial, and coordinating tasks. These teams involve close collaboration with various functions such as Operations, Quality, Regulatory, Procurement, Supply, Facility Management, Engineering, and PTOi.
Main responsibilities
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Acquiring and retaining technological knowledge related to products, processes, equipment and related suppliers.
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Setting up, coordinating, executing and reporting studies for the purpose of fact findings, (significant) investigations, root cause analyses, tech transfers, CAPEX projects, validations, changes or improvements.
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Lead or participate in project teams for the purpose of fact findings, (significant) investigations, root cause analyses, tech transfers, CAPEX projects, validations, changes or improvements.
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The tasks within project teams are diverse and can include the following key deliverables: validation and engineering protocols, validation and engineering reports, (project) plans, risk analyses, changes, URS, VMP & qualification protocols and reports.
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Participating or leading peer groups around specific areas of knowledge.
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Setting up, maintaining and working with systems such as Organon quality management systems (QMS), SHE systems, change control and SAP. Improving processes, products, technologies and systems.
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The person concerned is responsible for implementing the company's policy in the field of GMP and SHE. In any case, this means ensuring that conditions are in place that enable colleagues and team to comply with the relevant laws, regulations and company rules regarding GMP and SHE during their work.
Your profile
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Higher professional education (HBO) level with a degree in chemical engineering, mechanical engineering, or another relevant field.
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Several years of relevant work experience in the pharmaceutical industry or a comparable multidisciplinary environment.
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Strong technical and technological orientation.
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Experience in drafting protocols, performing and reporting equipment qualifications, process and cleaning validations.
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Knowledge of primary, secondary, and tertiary packaging techniques and packaging materials
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Knowledge of GMP requirements, EHS guidelines, and Lean principles.
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Ability to maintain oversight, communicate effectively, and inspire others.
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Persuasive, critical, results-oriented, flexible, and proactive.
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Strong verbal and written communication skills in Dutch and English.
We offer
We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.
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Competitive salary and a 3% year-end bonus.
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35,5 days of leave.
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Attractive collective health care insurance package with considerable reduction rates.
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Solid Pension Plan.
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Incentive Plan (bonus).
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Commuting allowance.
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Numerous training, coaching and e-learning modules for long term job opportunities and development.
With Organon, your career is more than just a job — it’s a journey of purpose, impact, and leadership. Together, we are building innovative solutions that improve health and change lives around the globe. If you're ready to grow, lead, and be part of something bigger — we want to hear from you!
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
10%
Flexible Work Arrangements:
Not Specified
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
N/A
Number of Openings:
1
Requisition ID:R537219
