Package Engineering Senior Manager

Vertex Pharmaceuticals•Boston, MA

1d•Hybrid

About The Position

JOB TITLE : Package Engineering Senior Manager LOCATION : 50 Northern Ave ., Boston, Massachusetts, 02210 OPENINGS: 1 DUTIES : Represent department on cross-functional CMC sub-teams, with minimal guidance. Ensure positive and effective relationships with key suppliers of materials, technology, and manufacturing resources. Manage and design key packaging activities including packaging design and specification, equipment and tooling design and qualification, labeling, material selection , testing, and sourcing. Work effectively with multiple stakeholders including Pharmaceutical Sciences, Manufacturing Sciences & Technology, Regulatory Affairs, Project Management, Supply Chain, Quality, Marketing and other cross functional departments to meet project timelines and objectives . Review process performance to identify continuous improvement activities for commercial products. Lead technical transfer and process validation activities; responsible for authoring and reviewing packaging qualification and validation documents. Translate product specifications into Packaging Design Documentation, ensuring enough detail is captured for Process Development and Manufacturing purposes. Work with domestic and international CMO (Contract Manufacturing Organization) to implement packaging solutions for product launch. Prepare definitive specifications or revisions with appropriate testing . Develop packaging systems that align with User Requirements, Functional Requirements, and Regulatory requirements. Manage Change Control, work with Cross-Functional Team for Impact Assessment, and manage timely completion of activities while ensuring updates are made to relevant documents. Support technical aspects of New Product Commercialization by effectively utilizing knowledge and first-generation learnings to design and develop commercial product packaging. With cross-functional input, author and execute study protocols and applicable testing regimens, and document all Root Cause Analysis Reports. Perform technical risk assessment related to packaging design and processes for new and commercial released products. Position requires 20% domestic and international travel. Telecommuting permitted up to 40%.

Requirements

Employer will accept a Bachelor's degree in Packaging, Mechanical, Chemical, or Material Engineering , or a related field and 96 years of experience in the job offered or in a Package Engineering Senior Manager -related occupation.
In depth experience in one or multiple packaging disciplines including materials and closure systems, design of secondary and tertiary components, component compatibility, component qualification, equipment installation and qualification for Cell & Gene therapies, Biologics, Aseptic fill/ finish or Medical Devices/Combination type products.
In depth experience supporting packaging of medical device or pharmaceutical products from research, through registration, clinical trials, and commercial launch.
Experience with Container Closure Integrity (CCI) per USP <1207> , <1207.1> , <1207.2> , and <1207.3>
In depth experience with packaging design verification (sterilization, environmental conditioning, shelf-life testing, distribution simulation and packaging performance testing) and validation studies including formative or summative studies.
In depth experience with CAD 3D modeling (SolidWorks), drawings, 3D printing and product performance testing.
Advanced knowledge of cGMPs and associated regulatory consideration in a medical device or pharmaceutical environment.
Experience working with internal and external contract manufacturers.
Strong understanding and application of validation processes (IQ, OQ, PQ, and PV).
Comprehensive knowledge of Design Control and risk management including experience with Risk Analyses using d.F.M.E.A ., u.F.M.E.A and p.F.M.E.A tools.
Thorough understanding of c.G.x.P principles and practices, ISO 13485, ISO 14971, and 21 C.F.R. 820.
Strong understanding of statistical principles, including hypothesis testing and process capability analysis.
Experience with U.S. F.D.A. and E.U. Risk Analysis methods.
Familiarity with Root Cause Analysis relating to Process, Product or Packaging Development.
Position requires up to 20% domestic and international travel.
Telecommuting permitted up to 40%.

Responsibilities

Represent department on cross-functional CMC sub-teams, with minimal guidance.
Ensure positive and effective relationships with key suppliers of materials, technology, and manufacturing resources.
Manage and design key packaging activities including packaging design and specification, equipment and tooling design and qualification, labeling, material selection , testing, and sourcing.
Work effectively with multiple stakeholders including Pharmaceutical Sciences, Manufacturing Sciences & Technology, Regulatory Affairs, Project Management, Supply Chain, Quality, Marketing and other cross functional departments to meet project timelines and objectives .
Review process performance to identify continuous improvement activities for commercial products.
Lead technical transfer and process validation activities; responsible for authoring and reviewing packaging qualification and validation documents.
Translate product specifications into Packaging Design Documentation, ensuring enough detail is captured for Process Development and Manufacturing purposes.
Work with domestic and international CMO (Contract Manufacturing Organization) to implement packaging solutions for product launch.
Prepare definitive specifications or revisions with appropriate testing .
Develop packaging systems that align with User Requirements, Functional Requirements, and Regulatory requirements.
Manage Change Control, work with Cross-Functional Team for Impact Assessment, and manage timely completion of activities while ensuring updates are made to relevant documents.
Support technical aspects of New Product Commercialization by effectively utilizing knowledge and first-generation learnings to design and develop commercial product packaging.
With cross-functional input, author and execute study protocols and applicable testing regimens, and document all Root Cause Analysis Reports.
Perform technical risk assessment related to packaging design and processes for new and commercial released products.