Senior Pharmaceutical Process Engineer, Polymerics (extrusie)

Posted Yesterday
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Hiring Remotely in Molenstraat, Loon op Zand, NLD
Remote
Senior level
Healthtech • Pharmaceutical
The Role
Lead and support projects for polymeric drug product manufacturing (extrusion). Specify and procure equipment, run and report equipment qualifications, introduce new products/materials, perform process and cleaning validations, and investigate root causes and process improvements while collaborating with multidisciplinary stakeholders in a GMP environment.
Summary Generated by Built In

Job Description

Senior Pharmaceutical Process Engineer, Polymerics (extrusie)

De functie

Afwisselende werkdagen, samenwerking met diverse stakeholders en sterk technisch en technologisch inhoudelijke uitdagingen zijn enkele aspecten die de rol van Pharmaceutical Process Engineer omschrijven! Indien jij onze nieuwe collega wordt, dan word je namelijk de lead voor of zal je deelnemen aan diverse projecten die worden uitgevoerd binnen ons bedrijf. Hierbij is het nodig dat je effectief kunt (samen)werken in een complexe, lokaal en wereldwijd georiënteerde omgeving.

Organon houdt zich bezig met technologisch hoogwaardige productie, verpakking en distributie van geneesmiddelen voor onder andere anticonceptie, bevordering van vruchtbaarheid en anesthesie in een sterk gereguleerde GMP-omgeving. Naast tabletten (solids) en injectievloeistoffen (steriles) worden hier ook speciale producten gemaakt, zoals anticonceptiestaafjes en ringen op basis van polymeertechnologie (polymerics).

De afdeling Technical Operations is overkoepelend werkzaam voor de diverse productie-onderdelen (IPT’s) van Organon in Oss. De afdeling bestaat uit verschillende secties die technische en technologische ondersteuning geven. Het gaat hierbij om de productsecties: steriles, solids, polymerics en packaging, welke product- en procesondersteuning geven aan de operatie. De Pharmaceutical Process Engineer rapporteert aan het hoofd van één van deze secties.

Verantwoordelijkheden

  • Het definiëren, specificeren en het aanschaffen van nieuwe productieapparatuur en het opzetten, uitvoeren en rapporteren van kwalificaties aan deze apparatuur;

  • Het introduceren van nieuwe producten, materialen of componenten naar de productieafdelingen;

  • Het opzetten, uitvoeren, rapporteren van proces- en schoonmaakvalidaties.

  • Het opzetten, uitvoeren, rapporteren en/of coördinatie van onderzoeken en wijzigingen ten behoeve van de verbetering van bestaande installaties en productieprocessen;

  • Leidinggeven of bijdragen aan onderzoek naar de root cause die het gevolg zijn van afwijkingen in het productieproces;

Vereiste opleiding, ervaring en vaardigheden

  • HBO werk- en denkniveau met een opleiding op het gebied van chemische technologie, werktuigbouwkunde of een andere relevante richting;

  • Minimaal 5 jaar relevante werkervaring in de farmaceutische  industrie of een vergelijkbare multidisciplinaire omgeving;

  • Sterk technisch en technologisch georienteerd;

  • Ervaring met het opstellen van protocollen, uitvoeren en rapporteren van apparatuur kwalificaties, proces- en schoonmaalvalidaties;

  • Kennis van GMP-eisen, EHS-richtlijnen en Lean-principes;

  • Je weet overzicht te behouden, bent communicatief en kunt anderen enthousiasmeren;

  • Je bent overtuigend, kritisch, resultaatgericht, flexibel en je neemt initiatief;

  • 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:

  • Een competitief salaris;

  • 35,5 vakantiedagen;

  • 8% vakantietoeslag en 3% eindejaarsuitkering;

  • Incentive Plan;

  • Een uitstekend pensioen;

  • Reiskostenvergoeding;

  • Ouderschapsverlof voor beide ouders;

  • 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

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:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Skills Required

  • HBO degree in chemical technology, mechanical engineering, or a related field
  • Minimum 5 years relevant experience in the pharmaceutical industry or similar multidisciplinary environment
  • Experience defining, specifying, procuring, commissioning and qualifying production equipment (equipment qualification/IQ OQ PQ)
  • Experience introducing new products, materials or components to production
  • Experience setting up, executing and reporting process and cleaning validations
  • Experience setting up, executing, reporting and/or coordinating investigations and change controls for process improvement and root-cause analysis
  • Knowledge of GMP requirements, EHS guidelines and Lean principles
  • Strong technical orientation, communication and leadership skills; ability to collaborate and influence stakeholders
  • Fluent Dutch and English, both written and verbal

Organon Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Organon and has not been reviewed or approved by Organon.

  • Strong & Reliable Incentives Quarterly bonuses and performance-based long-term incentives are frequently emphasized as meaningful components of total rewards, sometimes contrasted favorably with larger pharmaceutical firms. Recognition programs and an annual incentive process reinforce a pay-for-performance approach.
  • Parental & Family Support Twelve weeks of gender-neutral paid parental leave and twenty days of bereavement leave, including coverage for pregnancy loss, signal a robust family support offering. Caregiving concierge services and flexible leave practices further strengthen support for caregiving needs.
  • Retirement Support Retirement plans include employer contributions across many markets, with U.S. materials highlighting matching and additional company retirement contributions. This structure is presented as a core part of the financial benefits package.

Organon Insights

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The Company
HQ: Jersey City, NJ
6,952 Employees

What We Do

Organon is a global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines across a wide array of conditions and diseases. Our mission is to deliver impactful medicines and solutions for a healthier every day. This site is intended for residents of the United States and its territories. You are reminded to protect yourself against recruiting fraud from individuals, organizations or other entities claiming to represent Organon. All official Organon recruitment emails will come from accounts formatted as [email protected] or [email protected], and Organon will never conduct interviews by chat or email, or make job offers through social media or online forums. All candidates for roles at Organon will first meet with a recruiter and interview team, via Teams or in person. Organon will never ask you to make financial transactions on its behalf or ask you to receive or ship packages or goods. For more information on adverse event reporting, visit http://bit.ly/AEReporting. To read our community guidelines, visit http://bit.ly/OrganonCommunityGuidelines. Follow us on Twitter at Organon (@OrganonLLC). Follow us on Instagram at Organon (@OrganonLLC).

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