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Equipment Packaging Engineer
Equipment Packaging EngineerACL Digital • New Albany, OH, US
Equipment Packaging Engineer

Equipment Packaging Engineer

ACL Digital • New Albany, OH, US
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Title : Packaging Engineer

Location : Cambridge, MA 02138 ONSITE

Duration : 24+ months

Description :

Swing shift - candidates need to have flexibility for different shifts. Dayshift / Nightshift

Ideal Candidate : B.S. and 4 years of GMP experience, Packaging equipment experience,

technical writing & Document management system experience - Kneat or Viva preferred

The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations in New Albany, Ohio .

This is a technical leadership role requiring application of advanced engineering principles in equipment, devices, process optimization, and manufacturing support. The position requires on-site support and be able to work flexible schedule based on operation demands and both on-site work and ~20% travel

Key Functions & Outputs

Project Management :

  • Support technical transfer of product portfolio into the Ohio site.
  • Drive continuous improvement in device assembly and packaging line capacity / performance.
  • Communicate across the network to deliver technical milestones.

Technical Leadership :

  • Act as site expert in automated / semi-automated device assembly.
  • Lead commissioning, qualification, and validation (CQV) of GMP equipment.
  • Own and maintain the site master validation plan.
  • Operational Excellence :

  • Analyze, design, and implement manufacturing / business process improvements.
  • Drive productivity, throughput, and efficiency gains.
  • Quality and Document Management Systems :

  • Able to author and manage various documents / protocols / reports
  • Deviation / CAPA / EV Owner
  • Change Control Owner
  • Relationships :

  • Build networks with commercial and clinical operations.
  • Provide support for equipment standardization, troubleshooting, and performance trending
  • Preferred

    Combination product assembly equipment expertise

    Cross-functional project leadership experience

    Strong teamwork and communication skills

    Direct experience in devices, combination products, and packaging operations

    Supplier management experience (FDP equipment vendors)

    Adaptability in regulated, fast-paced environments

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    Packaging Engineer • New Albany, OH, US

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