Job Details

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