Overview
On Site
BASED ON EXPERIENCE
Contract - Independent
Contract - W2
Contract - 24+ mo(s)
Skills
GMP
PACKAGING
EQUIPMENT
KNEAT
VEEVA
ENGINEER
COMBINATION PRODUCT
COMBINATION PRODUCTS
MEDICAL DEVICES
MEDICAL DEVICE
SURGICAL
INJECTOR
MOLD
Job Details
Payrate: $38.00 - $42.00/hr.
Summary:
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
Responsibilities:
Qualifications:
Preferred:
Top 3 Must Have Skill Sets:
Pay Transparency: The typical base pay for this role across the U.S. is: $00.00 - $00.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ().
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-22501
Summary:
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
Responsibilities:
- 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
Qualifications:
- Doctorate; OR Master s +2 yrs GMP; OR Bachelor s +4 yrs GMP; OR Associate s +8 yrs GMP; OR HS/GED +10 yrs GMP
- B.S. and 4 years of GMP experience, Packaging equipment experience, technical writing & Document management system experience - Kneat or Viva preferred
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
Top 3 Must Have Skill Sets:
- 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.
Pay Transparency: The typical base pay for this role across the U.S. is: $00.00 - $00.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.
For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ().
Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human based decision making in employment decisions. By applying to this position, you agree to Aditi s use of AI technology, including calls from an AI Voice Recruiter.
#AditiConsulting
#25-22501
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.