CQV / Process Development Engineer – Minitab SME

Job Title: CQV / Process Development Engineer Minitab SME
Company: Intellectt Inc.
Location: New Albany, OH
Employment Type: W2 Contract
Pay Rate: $45 50/hr
Work Arrangement: Onsite

Job Summary
Seeking a hands-on CQV / Process Development Engineer to support commercial GMP manufacturing of combination products. The engineer will lead qualification, process characterization, optimization, and validation of automated and semi-automated assembly and packaging equipment. Strong Minitab expertise and the ability to work independently on night shift are essential.

Key Responsibilities

• Lead and execute CQV activities, troubleshoot equipment on the manufacturing floor, and support production readiness.

• Author and execute qualification protocols, validation plans, technical reports, and summary reports.

• Use Minitab for process capability studies (Cp/Cpk), MSA/Gage R&R, hypothesis testing, regression, and DOE.

• Assess critical process parameters and improve process performance using statistical analysis.

• Lead deviations, root cause investigations, and corrective actions.

• Maintain documentation in KNEAT, Veeva, TrackWise, or similar systems.

Required Qualifications

• Hands-on CQV experience in GMP pharmaceutical or biotechnology manufacturing.

• Experience with combination products, device assembly, and/or packaging equipment.

• Demonstrated proficiency in Minitab and statistical process analysis.

• Strong protocol authoring, technical writing, troubleshooting, and technical leadership skills.

• Ability to make sound technical decisions with limited oversight and work weekday and weekend night shifts as required.

Key Skills:

CQV, Commissioning & Qualification, Process Development, GMP Pharmaceutical/Biotechnology Manufacturing, Combination Products, Automated & Semi-Automated Assembly Equipment, Packaging Equipment, Minitab, Statistical Process Analysis, Cp/Cpk, MSA, Gage R&R, DOE

Recruiter Contact:

Rudra Prasad Kunnath
Email:

prasad.kunnath@intellectt.com

Benefits: Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.

• Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

• Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.