Associate Director, Engineering - Packaging Technology
NCBiotech, Rahway, NJ, United States
Job Description
This role serves as an essential part of the External Manufacturing & Network Equipment team, providing technical leadership and support to the company's internal & external packaging network. It focuses on developing and executing packaging and device assembly equipment and processes, including packaging equipment design & development, ensuring packaging process control and efficiency, and providing ongoing technical support across the lifecycle.
Essential Duties and 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 device component source changes.
Lead or support complex global and site‑centric capital and equipment projects, including new packaging equipment purchases, equipment transfer/relocation, and device component source change assessments.
Serve as the above‑site packaging and assembly equipment SME, providing direct technical support for troubleshooting, equipment performance, root cause analysis, and capability assessments.
Leverage packaging scientific/technical concepts and techniques such as mechanical & electrical knowledge, automation, AutoCAD/SolidWorks, equipment validation, Lean Manufacturing, GMP, safety standards, project management, and preventive & predictive maintenance to resolve issues.
Collaborate with the Serialization Center of Excellence and packaging sites on serialization strategy, implementation, monitoring, and troubleshooting.
Establish and maintain packaging equipment specification standards across multiple platforms (Bottle, Blister, Vial, Pre‑filled syringe, Autoinjector, etc.) and evaluate new technologies for compatibility.
Education Minimum Requirement
Bachelor's degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (Chemical Engineering, Material Engineering).
Required Experience and Qualifications
Minimum of 10 years’ experience in the pharmaceutical, biotechnology, or medical device industry, with 3–5 years in a leadership role.
Demonstrated success developing and implementing equipment standards across multiple sites and supporting packaging equipment design, development, and qualification.
Strong background in device, combination product, pharmaceutical packaging equipment and related scientific/technical concepts.
Broad experience with devices and combination products, covering design control, product transfer, and technology transfer for new and existing facilities.
Exceptional project management skills from initiation through close‑out.
Extensive GMP knowledge and expertise in qualification & validation, root cause analysis, change control, deviation management, and cleaning qualification.
Expert grasp of scientific/technical concepts such as mechanical & electrical knowledge, automation, AutoCAD/SolidWorks, Lean Six Sigma, GMP, safety, preventive maintenance, serialization, VOC, process capability, and root cause analysis.
Experience with quantitative decision tools for root cause analysis, risk management, and options analysis.
Leadership qualities: collaboration, change management, accountability, adaptability in cross‑functional teams.
Track record of operating autonomously to coordinate, communicate, and supervise technical issues.
Knowledge of cGMP, FDA, EMA, and other international regulatory requirements.
Strong analytical, decision‑making, and communication skills.
Required Skills
Biopharmaceutical Industry, Change Management, Combination Products, Cross‑Functional Teamwork, Detail‑Oriented, Deviation Management, Engineering Standards, GMP Compliance, Lean Manufacturing, Management Process, Mechanical Engineering, Medical Devices, Packaging Engineering, Packaging Equipment, Packaging Optimization, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management, Root Cause Analysis (RCA), Technical Issues, Technical Leadership, Technical Projects.
Benefits
Competitive salary range $129,000.00 – $203,100.00. Eligible for annual bonus and long‑term incentives where applicable.
Comprehensive benefits package: medical, dental, vision, healthcare insurance for employee and family; retirement 401(k); paid holidays, vacation, compassionate and sick days.
Location Requirements
US and Puerto Rico Residents Only.
San Francisco Residents Only: Eligible applicants with arrest and conviction records under the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only: Eligible applicants with criminal histories under the City of Los Angeles Fair Chance Initiative.
Other Details
Travel: 25%.
Flexible work arrangement: hybrid (three on‑site days, one remote).
VISA Sponsorship: No.
Job posting end date: 04/15/2026.
Requisition ID: R381961.
Equal Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or other legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
#J-18808-Ljbffr
Essential Duties and 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 device component source changes.
Lead or support complex global and site‑centric capital and equipment projects, including new packaging equipment purchases, equipment transfer/relocation, and device component source change assessments.
Serve as the above‑site packaging and assembly equipment SME, providing direct technical support for troubleshooting, equipment performance, root cause analysis, and capability assessments.
Leverage packaging scientific/technical concepts and techniques such as mechanical & electrical knowledge, automation, AutoCAD/SolidWorks, equipment validation, Lean Manufacturing, GMP, safety standards, project management, and preventive & predictive maintenance to resolve issues.
Collaborate with the Serialization Center of Excellence and packaging sites on serialization strategy, implementation, monitoring, and troubleshooting.
Establish and maintain packaging equipment specification standards across multiple platforms (Bottle, Blister, Vial, Pre‑filled syringe, Autoinjector, etc.) and evaluate new technologies for compatibility.
Education Minimum Requirement
Bachelor's degree in Packaging Science/Engineering, Mechanical Engineering, or a related technical discipline (Chemical Engineering, Material Engineering).
Required Experience and Qualifications
Minimum of 10 years’ experience in the pharmaceutical, biotechnology, or medical device industry, with 3–5 years in a leadership role.
Demonstrated success developing and implementing equipment standards across multiple sites and supporting packaging equipment design, development, and qualification.
Strong background in device, combination product, pharmaceutical packaging equipment and related scientific/technical concepts.
Broad experience with devices and combination products, covering design control, product transfer, and technology transfer for new and existing facilities.
Exceptional project management skills from initiation through close‑out.
Extensive GMP knowledge and expertise in qualification & validation, root cause analysis, change control, deviation management, and cleaning qualification.
Expert grasp of scientific/technical concepts such as mechanical & electrical knowledge, automation, AutoCAD/SolidWorks, Lean Six Sigma, GMP, safety, preventive maintenance, serialization, VOC, process capability, and root cause analysis.
Experience with quantitative decision tools for root cause analysis, risk management, and options analysis.
Leadership qualities: collaboration, change management, accountability, adaptability in cross‑functional teams.
Track record of operating autonomously to coordinate, communicate, and supervise technical issues.
Knowledge of cGMP, FDA, EMA, and other international regulatory requirements.
Strong analytical, decision‑making, and communication skills.
Required Skills
Biopharmaceutical Industry, Change Management, Combination Products, Cross‑Functional Teamwork, Detail‑Oriented, Deviation Management, Engineering Standards, GMP Compliance, Lean Manufacturing, Management Process, Mechanical Engineering, Medical Devices, Packaging Engineering, Packaging Equipment, Packaging Optimization, Packaging Processes, Pharmaceutical Packaging, Process Optimization, Regulatory Requirements, Risk Management, Root Cause Analysis (RCA), Technical Issues, Technical Leadership, Technical Projects.
Benefits
Competitive salary range $129,000.00 – $203,100.00. Eligible for annual bonus and long‑term incentives where applicable.
Comprehensive benefits package: medical, dental, vision, healthcare insurance for employee and family; retirement 401(k); paid holidays, vacation, compassionate and sick days.
Location Requirements
US and Puerto Rico Residents Only.
San Francisco Residents Only: Eligible applicants with arrest and conviction records under the San Francisco Fair Chance Ordinance.
Los Angeles Residents Only: Eligible applicants with criminal histories under the City of Los Angeles Fair Chance Initiative.
Other Details
Travel: 25%.
Flexible work arrangement: hybrid (three on‑site days, one remote).
VISA Sponsorship: No.
Job posting end date: 04/15/2026.
Requisition ID: R381961.
Equal Opportunity Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or other legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities.
#J-18808-Ljbffr