Manager - Packaging

Key Stakeholders

• Internal:

  Supply Chain, R&D, Quality Assurance, Regulatory Affairs, Manufacturing

• External:

  Vendors, Consultants

Reporting Structure

• Reports to:

  Chief Manager Packaging Technology

Relevant Experience

• Bachelor's degree with

  1015 years

  of experience in the

  pharmaceutical industry

  (preferably sterile products) or

  medical device industry

• Proven experience in:

• Primary container design and specification development

• Supporting

  primary packaging-related regulatory filings

• Strong

  project management skills

  within Packaging and/or Engineering
• Experience writing

  technical documentation for regulatory files

  (e.g.,

  FDA 510(k)

  and

  CE Mark

  )
• Deep understanding of

  global packaging regulations

  and

  medical device regulatory requirements

Key Responsibilities

• Design

  packaging systems and medical devices

  for anesthetic drug products, including primary, secondary, and tertiary packaging
• Support the development of

  adaptors

  ,

  integrated closures

  ,

  kits

  , and

  vaporizers

• Develop

  3D CAD models

  using

  SolidWorks

  , including engineering drawings for product components
• Collaborate with

  Manufacturing

  ,

  Supply Chain

  , and

  Logistics

  to identify improvement opportunities
• Utilize

  3D printing/additive manufacturing

  for prototyping and low-volume production
• Conduct

  stability studies

  ,

  machine feasibility studies

  ,

  packaging trials

  , and support

  regulatory filings

• Prepare

  usability

  and

  human factor test protocols

  , conduct testing, analyze results, and compile reports
• Maintain

  Design History Files (DHF)

  and prepare technical documentation for

  regulatory submissions

• Develop and improve

  Design Control

  and

  Quality Management System (QMS)

  procedures
• Conduct

  root cause analyses (RCA)

  and implement

  corrective/preventive actions (CAPA)

• Develop and maintain

  project plans

  and manage budgets for packaging projects
• Initiate new packaging projects to drive

  process improvements

  and

  business impact

• Support

  sustainability

  and

  green packaging initiatives

  in line with organizational goals

Key Competencies

• Strong knowledge of

  packaging materials

  , processes, and technologies, including

  medical devices

• In-depth understanding of

  industry standards

  and

  regulatory guidelines

• Ability to identify and solve

  packaging design

  and

  process issues

• Skilled in managing

  multiple projects

  , timelines, and stakeholder communications
• Excellent

  interpersonal and cross-functional collaboration skills

Qualifications

Essential

• BS in Mechanical Engineering

  or

• Graduate in Packaging Technology

  with strong expertise in:

• Medical device development

• R&D product packaging development