3 Key Consulting, Inc. · 3 months ago
Engineer Senior, Process Development GMP Packaging - (JP14502)
New Albany, OH
Full-time
Onsite
Mid, Senior Level
$42/hr - $46/hr
4+ years exp3 Key Consulting, Inc. is hiring an Engineer Senior, Process Development GMP Packaging for a consulting engagement with a leading global biopharmaceutical company. The role involves providing technical leadership in GMP operations, supporting product transfers, and driving continuous improvement in packaging processes.
AdviceCloud ComputingInformation TechnologyStaffing Agency
Responsibilities
Serve as the technical lead for FDP assembly and packaging equipment (new and existing)
Manage commissioning, qualification, and validation activities for GMP equipment, including ownership of the site’s master validation plan
Support technical transfer of new products into the site and ongoing optimization of packaging line performance
Provide manufacturing troubleshooting and equipment/process improvements
Build and leverage networks of technical experts across client’s global sites
Support operational excellence initiatives to increase throughput, productivity, and efficiency
Qualification
Required
B.S. and 4 years of GMP experience
Packaging equipment experience
Technical writing & Document management system experience - Kneat or Viva preferred
Expertise in Combination Product Assembly & Packaging Equipment
Strong knowledge of automated and semi-automated device assembly, validation, and troubleshooting
Experience in GMP-Regulated Environments
Hands-on experience with technical transfer, regulatory compliance, and supporting commercial manufacturing operations
Cross-Functional Project Leadership & Communication Skills
Proven ability to lead technical projects, work across teams, and effectively communicate in a regulated, fast-moving industry
Strong technical writing skills
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
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
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
Company data provided by crunchbase