Associate Director, Packaging Equipment Technology...

We aspire to be the premier research-intensive biopharmaceutical company. We’re at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and be part of a mission-driven organization that uses the power of leading-edge science to save and improve lives around the world.

This role serves as an essential part of the External Manufacturing & Network Equipment team, in providing technical leadership and support to our company’s internal & external packaging network, focusing on developing and executing packaging and device assembly equipment and processes including packaging equipment design & development, ensuring packaging process control and efficiency and providing on-going packaging and device technical support across the lifecycle.

The Packaging Technical Operations organization aims to be an industry leader in problem-solving, delivering robust and pragmatic technical solutions to accelerate the commercialization of new products, and ensuring an uninterrupted, compliant supply of commercialized products for the benefit of patients. The Associate Director of Equipment Engineering is integral to this mission. The successful candidate will possess deep process and equipment technical expertise for packaging and/or assembly, a strong track record in problem-solving, strategic acumen, and execution, along with leadership skills to lead complex cross functional projects.

Responsibilities

• Lead or support complex technical projects and/or equipment technology assessments within the packaging and Medical Devices & Combination Products (MDCP) space as part of new product introduction, product source change, and/or device component source changes.

• Lead or support complex global and site-centric capital and equipment projects, including new packaging equipment purchases, packaging equipment transfer/relocation, device component source change assessment, and packaging site operational & launch support.

• Serve as the above-site packaging and assembly equipment SME, providing direct technical support to the packaging network in areas of troubleshooting, equipment and End-to-End line performance & technology analysis.

• Leverage packaging scientific/technical concepts and techniques (e.g., mechanical & electrical knowledge, automation expertise, AutoCAD/SolidWorks competency, equipment validation & qualification, Lean Manufacturing/Six Sigma, GMP, Safety Standards, Project management, Preventive & Predictive maintenance, Serialization, VOC, process capability, root cause analysis) to resolve scientific/technical packaging issues.

• Work closely with our company’s Serialization CoE to support the implementation, monitoring, and troubleshooting of our serialization strategy.

• Establish and maintain specific packaging equipment specification standards in line with our company’s Same-Same component/equipment/process principles across multiple packaging platforms.

• Evaluate new technologies for compatibility with existing packaging lines and collaborate closely with package sites’ technology groups to ensure alignment.

Required

• A bachelor’s degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (such as Chemical Engineering or Material Engineering).

• Minimum of ten (10) years’ experience in the pharmaceutical, biotechnology, or medical device industry, with at least three (3) years in a leadership role (i.e., Maintenance, Operation and/or Engineering).

• Demonstrated success in developing and implementing equipment standards across multiple manufacturing or packaging sites.

• Strong background in medical device, combination product, pharmaceutical packaging equipment, and operational process.

• Broad experience with devices and combination products, covering design control to product and technology transfer for both new and existing packaging facilities.

• Exceptional project management skills, from conception and initiation through project close-out.

• Thorough knowledge and proven expertise in GMP application and quality systems, particularly in process and equipment qualification & validation, root cause analysis, change control, deviation management, and cleaning qualification.

• Extensive experience with quantitative decision tools for root cause analysis, risk management, and options analysis.

• Strong knowledge of cGMP, FDA, EMA, and other international regulatory requirements.

• Strong analytical and decision-making abilities, combined with outstanding oral and written communication skills.

Preferred

• Advanced practical knowledge of techniques applicable to packaging and device assembly equipment and processes.

• Experience in operating autonomously to offer strong coordination, communication, and supervision on all technical issues.

• Proven track record in operating in a fast-paced environment to resolve technical issues while meeting customer needs in a compliant manner., Biopharmaceutical Industry, Biopharmaceutical Industry, Biotechnology, Change Controls, Change Management, Combination Products, Cross-Functional Teamwork, Deviation Management, Engineering Standards, Equipment Experience, GMP Compliance, Good Manufacturing Practices (GMP), Lean Manufacturing, Lean Six Sigma (LSS), Manufacturing, Mechanical Engineering, Medical Devices, Medical Devices Design, Medical Device Technologies, New Product Introduction Process, Packaging Engineering, Packaging Equipment, Packaging Optimization, Packaging Processes, Pharmaceutical Packaging {+ 8 more}

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

The salary range for this role is

$129,000.00 - $203,100.00

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.