Merck · 4 hours ago
Associate Director, Engineering - Packaging Technology
USA - North Carolina - Wilson
Full-time
Hybrid
Lead/Staff, Director/Executive
$129K/yr - $203K/yr
10+ years expMerck is a leading company in the pharmaceutical industry, seeking an Associate Director of Engineering focused on Packaging Technology. This role involves providing technical leadership and support for packaging equipment and processes, ensuring compliance and efficiency across the packaging network.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Responsible to 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
The incumbent will lead or support complex global and site-centric capital and equipment projects. These projects would include new packaging equipment purchases, packaging equipment transfer/relocation, device component source change assessment, and packaging site operational & launch support. This will include approximately 30% travel on average with occasional peaks during critical milestones
Serving as the above-site packaging and assembly equipment SME. Individual will lead or provide direct technical support to the packaging network in areas of trouble shooting of the packaging operation, equipment and End-to-End line performance & technology analysis (i.e., continuous improvement, root cause analysis, equipment technology & capability assessments.)
The incumbent will be required to 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 mgmt., Preventive & Predictive maintenance, Serialization, VOC, process capability, root cause analysis and etc.)) and effectively apply them in daily work to resolve scientific/technical packaging issues
The successful candidate will be responsible for working closely with our company's Serialization CoE pertaining to our company's serialization strategy and to serve as the SME to collaborate with internal packaging sites, in North America, of its implementation, monitoring and troubleshooting support
The qualified candidate will be accountable to establish and maintain specific packaging equipment specification standards in line with our company's Same-Same component/equipment/process principles across multiple packaging platforms (e.g., Bottle, Blister, Vial, Pre-filled syringe, Autoinjector and etc.) In some cases, the individual will need to evaluate new technologies for compatibility with existing packaging lines and to collaborate closely with package sites’ technology groups to ensure alignment
Qualification
Required
A bachelor's degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (such as Chemical Engineering or Material Engineering) is mandatory
Minimum of 10 years' experience in the pharmaceutical, biotechnology, or medical device industry, with at least 3-5 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 along with extensive practical knowledge in supporting packaging equipment design, development and qualification
Strong background in the medical device, combination product, pharmaceutical packaging equipment and operational process and related scientific/technical concepts and techniques
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
Expert grasp of relevant scientific or technical concepts (e.g., mechanical & electrical knowledge, automation expertise, AutoCAD/SolidWorks competency, equipment validation & qualification, Lean Manufacturing/Six Sigma, GMP, Safety Standards, Project mgmt., Preventive & Predictive maintenance, Serialization, VOC, process capability, root cause analysis and etc.) to handle routine and complex tasks, along with advanced practical knowledge of techniques applicable to these tasks
Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis
Exhibited leadership qualities such as working collaboratively, managing change, accountability, adaptability and other attributes in a diverse, cross-functional team
Proven track record in operating in a fast-paced operating environment to resolve technical issues while meeting customer needs in a compliant manner are essential
Demonstrated capability in operating autonomously to offer strong coordination, communication, and supervision on all technical issues
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
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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