Engineer Senior

Description

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

10% travel required - Must be able to travel internationally for work (Europe/Canada)

Ideal Candidate: B.S. and 4 years of GMP experience, Packaging equipment experience, technical writing & Document management system experience - KNEAT or Veeva highly preferred

The Senior Process Development Engineer – Packaging Equipment supports commercial GMP Final Drug Product (FDP) operations.

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 ~10% 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

Basic (Education & Experience)

• Doctorate (no experience required) OR Master’s 2 years GMP experience OR Bachelor’s 4 years GMP experience OR Associate’s 8 years GMP experience OR High School/GED 10 years GMP experience

Preferred Qualifications

• 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
• Operational excellence / continuous improvement mindset

Top Must Have Skill Sets

1.  GMP & Packaging Equipment Expertise

• Strong hands-on experience in GMP-regulated environments
• Direct experience with packaging / device assembly equipment (automated or semi-automated)
• Involvement in commissioning, qualification, and validation (CQV)

2. Technical Writing & Document Management Systems

• Proven ability to author and manage GMP documents (protocols, reports, validation docs)
• Experience with document management systems (preferably KNEAT or Veeva)
• Ownership of deviations, CAPAs, and change controls

3. Process Development & Continuous Improvement

• Ability to analyze and optimize manufacturing processes
• Experience driving efficiency, throughput, and performance improvements
• Strong technical leadership in process/equipment optimization
• Strong project management and team player skillset. Ability to work within different cross functional groups and coordinate projects.
• Nice to have: KNEAT/Veeva and Former experience managing projects

Day to Day Responsibilities

1. Equipment & Manufacturing Support

• Provide on-site support for GMP packaging and device assembly operations
• Troubleshoot equipment issues and improve reliability/performance
• Support automated and semi-automated assembly lines
• Monitor and trend equipment performance metrics

2. Process Improvement & Optimization

• Identify and implement process improvements to increase throughput and efficiency
• Analyze manufacturing data to drive continuous improvement initiatives
• Optimize packaging line capacity and performance

3. Documentation & Quality Systems

• Write, review, and manage GMP documents (protocols, reports, procedures)
• Own and manage deviations, CAPAs, and change controls
• Maintain and update the site master validation plan
• Use systems like KNEAT or Veeva for document control

4. Validation & Technical Projects (CQV)

• Lead or support commissioning, qualification, and validation (CQV) activities
• Support tech transfer of products into the Ohio site
• Ensure equipment and processes meet regulatory and quality requirements

5. Cross-Functional Collaboration

• Work with manufacturing, quality, engineering, and external vendors
• Coordinate with commercial and clinical teams
• Communicate progress on technical milestones and projects

6. Project & Vendor Management

• Support equipment-related projects and timelines
• Interface with equipment suppliers/vendors for troubleshooting and improvements
• Contribute to standardization efforts across sites

7. Flexible Operations Support

• Work swing shifts (day/night/weekend as needed)
• Provide support based on production demands
• Occasional travel (~10%)