The Senior Manufacturing Engineer will lead and manage projects within filling and packaging manufacturing streams. This role focuses on defining equipment specifications, improving process efficiency, reducing downtime, and supporting automation initiatives to ensure compliance, quality, and operational excellence in a cGMP environment.

Responsibilities

• 
  Plan, design, and implement new manufacturing equipment and packaging processes.

• 
  Lead cross-functional project teams to meet cost, quality, and performance goals.

• 
  Support equipment qualification (IQ/OQ/PQ), testing, and validation activities.

• 
  Develop and maintain manufacturing documentation, including SOPs and process records.

• 
  Identify opportunities for process optimization, automation, and cost reduction.

• 
  Ensure compliance with cGMP, ISO, and FDA regulations.

Required Skills

• 
  Bachelor’s degree in Engineering or related field.

• 
  5–6 years of experience in a
  cGMP manufacturing environment
  with automated filling and packaging systems.

• 
  Strong knowledge of
  equipment qualification (IQ/OQ/PQ)
  and process validation.

• 
  Proven ability to manage multiple projects in a matrixed organization.

• 
  Excellent analytical, troubleshooting, and communication skills.

Preferred Skills

• 
  Master’s degree in Engineering or related discipline.

• 
  Experience with
  automation, surface treatments, adhesive bonding, microdispensing
  , and
  injection molding
  .

• 
  Familiarity with
  medical device or diagnostics manufacturing
  and
  design transfer activities
  .

• 
  Knowledge of
  Material Science
  and continuous improvement methodologies.