Organon - Associate Director Packaging Engineer - Components - Merck (Hawaii)
Job Description
Our Engineers support internal and external manufacturing operations to continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Packaging, Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
Position Responsibilities:
+ This Associate Director packaging engineer leverages experience gained on scientific, technical, business issues, to lead packaging project teams and advise technical staff to solve complex packaging problems.
+ The ability to apply these in a fast-paced Technical Operations environment to resolve issues and meet customer needs in a compliant manner are at the core of this position
+ The incumbent generates and analyzes scientific data, reports the resulting information, and captures and disseminates knowledge in standard format for current and future use.
+ The position requires advanced knowledge, skills, and abilities to create and optimize business, technical, and compliance processes. Effective leadership of, or collaboration with, high-impact, complex cross-functional, and cross-divisional teams and initiatives is common. Key interfaces include Global Procurement, sites, Quality Ops, CMC Regulatory Affairs, and suppliers.
Some key areas of Responsibility include:
+ Design/Develop/improve packaging components
+ Knowledgeable with a wide range of packaging materials, both rigid and flexible
+ Support of complex global and site changes to primary, secondary, and tertiary packaging materials/ components.
+ Qualification of changes to distribution and thermal transport/ storage systems and methods for bulk and finished drug products.
+ Leading initiatives in Proactive Packaging Analytics and Robustness, problem-solving and continuous improvement.
+ Leading the development and execution of related strategic plans for Risk Assessments.
Education Minimum:
+ BS in Packaging Science, Materials Science, or similar
Required Experience and Skills:
+ 10+ years in a regulated environment.
+ 5+ years of hands-on with packaging materials/components, and packaging processes.
+ 2+ years 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.
+ Qualification of functional aspects of container closure systems, such as Child Resistance and Senior Friendly packaging.
+ Project management skills, from conception and initiation, through close-out.
+ Significant experience with packaging operations support, packaging materials/ components, and packaging processes.
+ Demonstrates Leadership Behaviors and Inclusive Behaviors.
+ Quantitative decision tools for Risk Management and options analysis.
+ Takes an end-to-end view of the supply chain to understand the upstream/downstream impact of actions taken at any node.
+ Guiding diverse and cross-functional teams.
+ The engineer 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:
+ Completes activities with the highest regard for all Company divisional and local site procedures for safety, quality, and regulatory compliance.
+ Excellent oral and written communication skills
+ Proven ability to provide technical leadership and apply technical skills in a fast-paced, complex environment.
+ In-depth understanding and proven expertise in the application of GMP’s, quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management, and cleaning qualification.
+ Advanced understanding of the relevant scientific/ technical concepts to execute routine and increasingly complex tasks; advanced working knowledge in the relevant scientific /technical techniques and is able to apply those techniques to routine and increasingly complex tasks.
+ Strong analytical skills and decision-making skills.
+ Technical lead for internal site-to-site Packaging Technical transfers, validations, Change Controls, and process improvements.
+ Stewardship of Global Packaging Technical Operations' Rapid Response business process for managing unplanned work. Liaising with Subject Matter Experts and responsible functions to triage incoming requests, develop solutions, and respond to business partners in a timely manner.
Preferred Experience and Skills:
+ Packaging Science/Engineering degree preferred.
+ Experience with parenteral packaging.
+ Experience with combination product packaging.
+ Demonstrated deep technical skills in the area of packaging components.
+ Experience with key manufacturing compliance and business systems: Trackwise change owner, MIDAS, SAP, etc.
+ Experience leading technical transfers Problem-solving, including the technical aspects of fact-finding, Root Cause Investigations, and development of robust preventive actions within the internal network and at suppliers.
+ Participating in periodic Business Review Meetings with suppliers of packaging materials and components.
\#Newco
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.
At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.
At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Remote Work
Shift:
Valid Driving License:
Yes
Hazardous Material(s):
Number of Openings:
1
**Requisition ID:** R106469
* This article was originally published here
