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.
Focus on developing and executing packaging and device assembly equipment and processes including packaging equipment design & development.
Ensure packaging process control and efficiency and provide on-going packaging and device technical support across the lifecycle.
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.
Lead complex cross functional projects and collaborate effectively with site-based and above-site based functional teams, aiming to align with the company's goals.
Responsible for leading or supporting complex technical projects and/or equipment technology assessments within the packaging and Medical Devices & Combination Products (MDCP) space as part of new product introduction and product source change.

Requirements

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.
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 to handle routine and complex tasks.
Extensive experience with quantitative decision tools for root cause analysis, risk management and options analysis.

Benefits

medical
dental
vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

packaging equipment designpackaging process controlequipment qualificationequipment validationroot cause analysischange controldeviation managementcleaning qualificationquantitative decision toolsproject management

Soft Skills

problem-solvingstrategic acumenexecutioncollaborationleadership