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Senior Specialist, External Manufacturing Engineering
3 months ago
The Global Packaging Technology External Manufacturing organization supports Organon's external manufacturing operations so that they remain operational, continuously improve and innovative. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including equipment, documentation, materials, and distribution.
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 support the technical interface between our company and packaging project teams and assist technical staff to solve complex packaging problems. You will assist in generating scientific data, reporting the resulting information and capture and disseminate knowledge in standard format for current and future use.
Responsibilities
Technology transfers, Qualifications, Validations, Process Improvements and Change Control;
Function independently and provide communication on all technical matters pertaining to the external packaging partners;
As a member of the ExM Packaging Focus Factory team, you will help to establish clear expectations, measure and monitor operational and quality performance associated with external packaging
Help to assure technical site readiness for all new product introductions or transfers;
Participate in periodic Business Review Meetings with external packaging partners;
Assist in 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.
Required Education, Experience, and Skills
Bachelor’s or Master’s degree in Packaging Science, Mechanical Engineering, Chemical Engineering, Materials Science, or similar;
5+ years of experience in a regulated environment;
3+ years of hands-on 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;
Experience with packaging operations support, packaging materials/ components, and packaging processes;
Competent analytical and decision making skills;
Good oral and written communication skills in English.
Preferred Education, Experience, and Skill
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.
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.
If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.
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
25%
Flexible Work Arrangements:
Remote Work
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID:R525475
