Associate Director External Manufacturing
il y a 1 semaine
Associate Director External Manufacturing Engineering - remote
This is a remote position and can be based in Amsterdam or Oss (The Netherlands), Heist-op-den-Berg (Belgium), Madrid (Spain), Cramlington (UK) or Dublin (Ireland) and requires an amount of travel between 10% and 20% of the time throughout Europe.
Welcome to our team
The Global Packaging Technology External Manufacturing organization supports our external manufacturing operations so that they remain operational, continuously improve and innovative.
With our extensive range of facilities and environments, the Engineers have opportunities across many diverse areas including equipment, documentation, materials, and distribution.
Purpose of the role
In this role you will be responsible for leading the technical interface with external packaging partners. These partners are Contract Manufacturing Organizations (CMO's) in the External Manufacturing (ExM) space.
You will collaborate with other functions (Quality, Operations, Supply Chain and Procurement) and specialist centers of excellence in the Science & Technology network where needed.
Working under general scientific and administrative direction, you will leverage experience gained on scientific, technical, and business issues, to lead the technical interface between our company and packaging project teams and advise technical staff to solve complex packaging problems.
You will generate and analyze scientific data, report the resulting information and capture and disseminate knowledge in standard format for current and future use.
Main responsibilities
- Technology transfers, Qualifications, Validations, Process Improvements and Change Control;
- Function independently and provide coordination, communication, and oversight on all technical matters pertaining to the external packaging partners;
- As a member of the ExM Packaging Focus Factory team, establish clear expectations, measure and monitor operational and quality performance associated with external packaging partners periodically;
- Provide technical expert consultation and review on commercial agreements;
- Assure technical site readiness for all new product introductions or transfers;
- Participate in periodic Business Review Meetings with external packaging partners;
- Lead complex changes of packaging images and primary, secondary, and tertiary materials/components and thermal transport/storage systems;
- Gather Information for Change Control
- Impact Assessments and Tasks.
Your profile
Required
- Bachelor's or Master's degree in Packaging Science, Mechanical Engineering, Chemical Engineering, Materials Science, or similar;
- 10+ years of experience in a regulated environment;
- 5+ years of handson experience with packaging operations support, packaging materials/components, and packaging processes;
- 2+ years of experience in a pharmaceutical site or External Manufacturing role (Operations, Technology, or Quality);
- Knowledge in the regulations of major markets in the Pharmaceutical industry, e.g. USFDA cGMPs, EMA;
- Significant experience with packaging operations support, packaging materials/ components, and packaging processes;
- Applies the following competencies in a manner that challenges and enhances overall operational effectiveness and routinely provides feedback and coaching to team members and collaborators on these skills;
- Strong analytical and decision making skills;
- Excellent oral and written communication skills in English.
- Experience with solid oral dose packaging;
- Experience with combination product packaging;
- Experience with key manufacturing compliance and business systems: GCM, ETQ, MIDAS, SAP, Ariba, Tracelink.
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.
Search Firm Representatives Please Read Carefully
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
25%
Flexible Work Arrangements:
Remote Work
Shift:
**Valid Driving Licen
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