Associate Director External Manufacturing Engineering - Remote > Heist-op-den-Berg > Joboolo BE :
Company : Organon Location : Heist-op-den-Berg Flanders From : Talent BE
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 roleIn 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 ExternalManufacturing (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 responsibilitiesTechnology 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 RequiredBachelor’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 hands-on experience with packaging operations support, packaging materials/components, and packaging processes;2+ years of experience in a pharmaceutical site or ExternalManufacturing 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. PreferredExperience 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 DescriptionWho 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. Annualized Salary RangeAnnualized 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:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites25%Flexible Work Arrangements:
