Senior Packaging Engineer

Job Description

A fantastic opportunity has arisen for a Senior Packaging Engineer.

This role serves as an essential part of the External Manufacturing & Network Equipment team, overseeing product and technology transfers to Contract Manufacturing Organizations (CMOs). The role will interact with external packaging partners, which are Contract Manufacturing Organizations in the ExM space. The individual will work closely with other ExM functions (Technology, Quality, Operations, Supply Chain, Procurement) and technology experts within the greater packaging community. The individual will leverage their scientific, technical, and business expertise to support teams in solving complex packaging issues, optimizing processes, and ensuring compliance, focusing on developing and executing primary and secondary packaging components for Small and Large Molecule assets, assembling Medical Device Combination Products, designing packaging equipment, and ensuring packaging process control and efficiency. The position requires strong technical skills in supporting and improving business, technical, and compliance processes, and collaborating within high-impact cross-functional teams.

• Support technology transfers, qualifications, validations, process enhancements, and change controls for Small and Large Molecule projects, medical devices, and combination products.
• Ensure compliant packaging and assembly process transfer, project management, site readiness, and execution excellence.
• Coordinate, communicate, and oversee technical matters with external packaging partners autonomously.
• Provide technical support for quality and supply investigations, and co-lead discussions on packaging processes, equipment, and components to identify root causes and develop corrective and preventative actions.
• Support technical evaluations of external packaging partners and create thorough assessments for partner selection.
• Participate in periodic Business Review Meetings with external packaging partners.
• Lead or support complex changes of packaging images and materials/components.
• Support the qualification of modifications to distribution and thermal transport/storage methods for finished packaging configurations.

Bring energy, knowledge, innovation to carry out the following:

What skills you will need:

In order toexcel in this role, you will more than likely have:

• Minimum of 5 years’ experience in medical device or combination product engineering and pharmaceutical field, with practical knowledge in packaging operations, materials, and processes.
• Experience in capital packaging equipment projects, including technology transfers, designing packaging lines, equipment installation and validation, and troubleshooting.
• Experience with devices and combination products, covering design control to product and technology transfer for both new and existing packaging facilities.
• Proficiency in project management from conception to closeout, with strong GMP and quality systems expertise.
• Solid understanding of scientific or technical concepts for routine and complex tasks, with advanced practical knowledge of applicable techniques.
• Experience with manufacturing change control compliance systems like Veeva and quantitative decision tools for risk management.
• Demonstrated leadership qualities, inclusive practices, and ability to work in a diverse, cross-functional team.
• Familiarity with the regulatory standards of key pharmaceutical markets, such as USFDA, cGMPs and EMA guidelines.
• Demonstrate commitment to continuous improvement by proactively adopting new strategies, drawing insights from experiences, and making informed decisions regarding risk-taking. Regard setbacks as valuable learning opportunities rather than impediments.
• Adopt a critical mindset in decision-making to ensure thorough analysis while considering potential impacts on key stakeholders.
• Strong analytical and decision-making abilities, combined with outstanding oral and written communication skills.
• Bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringinginclusive, talented, and committed people together.

Pleasedon'thesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs,please apply today.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

Relocation:

VISA Sponsorship:

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