Sr. Packaging Engineer

Company Name:
Astellas Pharma US Inc
_Purpose & Scope:_
Provide technical
expertise to packaging operations and maintenance to maximize APT's ability to produce the highest quality products at the lowest possible cost in a cGMP environment. Develop work practices, develop and train other members of the Astellas team. Manage small to large sized packaging projects.
_Essential Job Responsibilities:_
May be required to supervise one or two associate packaging engineers or packaging engineering specialists.
Design, write and approve required packaging specifications, production records, and procedures to define packaging processes.
Prepare and execute packaging equipment testing, qualification, and validation as required. Conduct the following: site acceptance tests, installation qualification, operational qualification, packaging/performance qualification, and packaging validations.
Identify, evaluate and implement packaging process improvement activities. Direct efforts to eliminate non-conformance issues through process definition and optimization.
Develop technical guidance and coordination with other packaging groups and manufacturing sites for packaging transfer, validation and on-going packaging. Assist or train other APT members as appropriate with respect to packaging process details and performance.
Manage artwork and labeling process activities.
Consult with manufacturing personnel regarding packaging improvements and develop solutions based on input.
Take the lead to troubleshoot problems associated with packaging equipment and systems, including material related issues. Determine possible solutions to problems based on facts gathered and gain consensus on required remediation.
Evaluate, specify, and recommend new packaging equipment with emphasis on capacity, output, and cost control. Establish required operating and performance parameters for new equipment. Manage the delivery, installation, qualification, and validation as required.
Develop and manage shipping studies and transportation tests. Oversee if performed at a contract packager.
Provide budgetary input for capital and expense items, including recommendations for new packaging equipment and technologies.
Provide timely input to supervisors, project managers, and operations personnel as to project activities.
_Quantitative Dimensions:_
Maintains communication with internal Astellas sites, employees, and outside vendors and suppliers of packaging components for all current packaging components, new components, and potential modification of the acceptance criteria in the packaging process, preventing adverse impact.
Works with many APT departments including primary client group of APT operations (packaging)
Impacts quality of APT solid oral dose global products
Organizational Context:
Reports to Manager Project and Process Management
No direct reports
Minimum 6 years packaging engineering experience with BS; 4 years experience with MS.
BS in Packaging Science or engineering required.
Knowledge of the theory/operation of pharmaceutical packaging processes, various packaging materials and equipment is required.
In-depth knowledge of cGMPs and understanding of regulatory requirements related to packaging.
Position requires a high degree of initiative, independence, and decision making skills to provide the leadership necessary to manage resources insuring on-time delivery of accurate, compliant packaging.
Must have excellent interpersonal skills, be highly self-motivated, well organized, and be able to develop alternative solutions to complex issues.
Look for ways to improve and promote quality and demonstrate accuracy and thoroughness.
Strong oral/written communication skills. Attention to detail required. Ability to work independently and as a team member.
Minimal supervision required.
Working knowledge of Microsoft software (Word and Excel).
Must be able to read, write and understand the English language (statement common to all job descriptions).
Must be able to read and perform work to specified written instructions and procedures. Must be able to climb three stories of stairs. Must have the ability to perform while wearing required personal protective equipment: respiratory protections PAPR, eye protection, gloves, uniform, safety shoes and hearing protections where required.
Packaging Science or Mechanical Engineering degree preferred
Experience in a pharmaceutical manufacturing technical support role in a pharmaceutical, nutritional or food industry; oral solid dose packaging equipment is preferred.
Experience with AutoCAD, Access, SharePoint, and/or Project is a plus.
Experience with SCADA systems.
Project management experience.
Additional knowledge in at least one of the following areas is beneficial: statistical inference, SPC, process capability, DOE, sampling plans, or risk assessment.

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