Packaging jobs in United States, Pennsylvania, West Whiteland Township

In this role, you will be responsible for managing the day-to-day operations of the Packaging and Performance (P&P) testing group and initiatives. Supervise the team to assure safety and conformity with processes and procedures to reduce risks and improve compliance and productivity. Monitor and achieve team metrics, provide direction to analysts, and manage their performance.

• Supervise the day to day activities of the P&P team and act as mentor.
• Preparation and reporting of KPI’s
• Knowledge and understanding of the following P&P test techniques and capabilities:
  • Sample/Device Performance testing (ISO 11040 and 11608, etc.), Compendial testing (USP 381 and382), Force analysis, CAD and 3D design, Lab Scale Filling and Assembly, Method development and validation
• Assist 2nd Shift, CCI and P&P Manager with management and allocation of resources and assignments
• Assure that analysts have been adequately trained for their role.
• Review and release final reporting to internal and external customers as it pertains to the group. Communicate updates for all projects timely
• Follow required cGMP regulations and assure compliance per internal QA procedures
• Supervise and approve laboratory quality investigations to support internal and external customers
• Manage the development and validation of numerous analytical techniques
• Implement continuous improvement/lean activities and events for the group
• Write, review, and approve documents (Investigations, Work Instructions, SOP’s, etc.)
• Support internal and external audits as required
• Hire new employees ensuring that their qualification and skills set fit with the needs of the individual role
• Independently drive projects from initiation through completion
• Lead communication with internal and external customers
• Provide direction to his/her group and assist in providing systems and direction to control costs, reduce risks and improve productivity
• Assure Safety procedures are followed and identify any safety risks with preventative action
• Maintain cognizance of current validation requirements.
• Work independently and as part of a team with self-motivation, adaptability, and a positive attitude
• Other duties as assigned

• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read & write, speak in front of groups, express & exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems

• Bachelor’s degree in Chemistry, Mechanical Engineering or equivalent experience

• Minimum 6 years of experience in laboratory environment
• Minimum 1-3 years of personnel management or project management

• cGMP
• ISO and USP/EP compendia, Specifically ISO 11040, 11608, and USP 381, 382. Basic statistical understanding
• Understanding of CAD Design, 3D Printing, Minitab, Zwick, Instron or Solidworks/ Solidworks PDM
• Strong oral and written communication skills and attention to detail required
• Awareness to relevant Company policies as they are related to the position covered by this Job Description
• Experience with Instron, Zwick, Benchtop Assembly Instrumentation, Medical Device EDDO’s, and Method Development and Validation strategies
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

• Job-related activities that require a physical activity such as standing in laboratory environment
  • Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms.
  • Employee may be required to lift heavy objects (up to 25 lbs.) without assistance
• Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)

In this role, you will be responsible for planning, organizing, and leading projects to support the development of new packaging systems and or components that enhance and preserve West’s high value products. The ideal candidate will drive technical projects, work with cross-functional development teams, and work with strategic suppliers to develop new packaging systems for West’s HVP offerings. You will act as a subject matter expert for system and component packaging and drive technical decisions which support West’s business objectives. Key responsibilities include project management, testing coordination and execution, specification / drawing development, Design History File (DHF) documentation creation and cross functional collaboration while engaging with various project teams and functional groups. As a Senior Engineer, you will be responsible for mentoring more junior engineers within the group and identifying innovative solutions to broaden West’s portfolio. The incumbent will:

1. Demonstrate accountability for the successful and timely achievement of goals
2. Work independently only with strategic guidance in the most complex situations
3. Interpret internal and external business issues and unmet needs and take a broad perspective to define/plan/lead/develop solutions.

• Technical packaging lead for Integrated Systems R&D efforts related to product design and development processes from conceptualization to commercialization.
• Engage with cross-functional teams that include R&D, Pharma Processing, Marketing, Regulatory, Quality and Supply Chain to develop new packaging solutions.
• Develop innovative packaging solutions to support business growth and to enhance West’s position as an industry leader in drug delivery.
• Responsible for creation and maintenance of packaging elements for Design History File (DHF) for all assigned projects including Design Inputs, Risk Analysis (FMEAs), test protocols, and Design Verification.
• Support customers and suppliers as required for development of new packaging solutions. Maintain effective communications and working relations with all external parties.
• Coordinate packaging testing activities for engineering studies and protocols through internal and contract packaging laboratories.
• Deliver technical reports, executive summaries, and presentations to communicate activities and timelines to management and core team members.
• Identify and drive continuous improvement efforts within the packaging group.
• Other duties as assigned.
• Maintain effective communications and working relations with all external parties.

• Education or Equivalent Experience: Bachelor's in Packaging, Mechanical, Materials, or Chemical Engineering, or related engineering discipline
• Master's degree preferred

• Experience: 5-8 years of experience in development of packaging, medical devices, or combination products
• Previous experience in packaging development of sterile barrier systems
• Experience leading technical projects from concept through commercialization
• Experience in working under requirements of Quality Management System in a regulated environment
• Experience in communicating complex technical concepts to customers and internal stakeholders

• Thorough understanding of global testing standards and regulatory requirements related to sterile barrier packaging
• Excellent interpersonal and written/verbal communication skills
• Working understanding and application of fundamental engineering principals.
• Strong technical writing abilities.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety policy and quality at all times.