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Engineer Senior

Aditi Consulting

New Albany, OH

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JOB DETAILS
SALARY
$40–$43 Per Hour
SKILLS
Artificial Intelligence (AI), Assembly Equipment, Assembly Line, Automated Assembly Equipment, Automotive Automation, Change Control, Commissioning, Communication Skills, Consulting, Continuous Improvement, Cross-Functional, Data Analysis, Document Control, Document Management, Documentation, GMP (Good Manufacturing Practices), Identify Issues, Leadership, Manufacturing, Manufacturing Analysis, Manufacturing/Industrial Processes, Messaging Technology, On Site Support, Performance Management, Performance Metrics, Process Development, Process Improvement, Product Packaging, Product Support, Project/Program Coordination, Project/Program Management, Purchasing/Procurement, Quality Engineering, Regulations, Reliability Engineering, Secondary School, Short Messaging Service (SMS), Speech Technology, State Laws and Regulations, Team Player, Technical Leadership, Technical Support, Technical Writing, Telephony, Validation Plan, Vendor/Supplier Management, Vendor/Supplier Relations, Writing Skills
LOCATION
New Albany, OH
POSTED
30+ days ago
Payrate: $40.00 - $43.00/hr.
 
Responsibilities:
  • 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
 
  • 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
 
  • 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
 
  • 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
 
  • Cross-Functional Collaboration:
  • Work with manufacturing, quality, engineering, and external vendors
  • Coordinate with commercial and clinical teams
  • Communicate progress on technical milestones and projects
 
  • Project & Vendor Management:
  • Support equipment-related projects and timelines
  • Interface with equipment suppliers/vendors for troubleshooting and improvements
  • Contribute to standardization efforts across sites
 
Qualifications:
  • 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:
  • 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:
  • 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)
 
  • 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
 
  • 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
 
 
Pay Transparency: The typical base pay for this role across the U.S. is: $40.00 - $43.00 /hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match,  life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law. 
 
Consent to Communication and Use of AI Technology: By submitting your application for this position and providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated (including auto telephone dialing systems or automatic text messaging systems), pre-recorded, AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliates at the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. Message frequency may vary.
You represent and warrant that the email address(es) and/or telephone number(s) you provided to us belong to you and that you are permitted to receive calls, text (SMS) messages, and/or emails at these contacts. You also acknowledge and agree to Aditi Consulting LLC’s use of AI technology during the sourcing process, including calls from an AI Voice Recruiter. AI is used solely to gather data and does not replace human-based decision-making in employment decisions. Calls may be recorded.
 
Consent is not a condition of purchasing any property, goods, or services. You may revoke your consent at any time by replying “STOP” to messages or by contacting

privacy@aditiconsulting.com

. 
 
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
 
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Aditi Consulting

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