Process Engineer Equipment Validation & Packaging Systems

Job Title: Process Engineer Equipment Validation & Packaging Systems

Location: Columbus, OH

Work Arrangement: Onsite

Experience Level: 7+ Years

Pay rate: $45-$50/hr on W2

Skills: equipment characterization, IQ/OQ/PQ, and requalification automated pharmaceutical packaging equipment reliability, throughput, and process capability CAPAs GMP change control.

Job Summary:

Seeking an experienced Process Engineer to support equipment validation, requalification, troubleshooting, and continuous improvement for commercial pharmaceutical packaging lines. The role is approximately 60% validation/qualification and 40% hands-on process engineering. Key Responsibilities:

Lead equipment characterization, IQ/OQ/PQ, and requalification activities.

Develop, execute, and document validation protocols and technical reports.

Provide hands-on engineering support for automated pharmaceutical packaging equipment.

Troubleshoot equipment issues and improve reliability, throughput, and process capability.

Support packaging systems including autoinjectors, sealers, palletizers, serialization, Cognex vision, conveyors, labeling, and case packing.

Lead root cause investigations, deviations, CAPAs, and equipment improvement initiatives.

Support equipment modifications through GMP change control.

Collaborate with Manufacturing, Validation, Quality, Maintenance, and Packaging Engineering teams. Requirements:

7+ years of engineering experience in pharmaceutical/biopharmaceutical manufacturing.

Bachelor's degree in Mechanical Engineering preferred; related engineering degrees considered.

Strong hands-on experience with equipment validation and qualification.

Proven experience with IQ/OQ/PQ, characterization, and requalification.

Pharmaceutical packaging equipment experience is highly preferred.

Strong mechanical aptitude and troubleshooting skills.

Knowledge of cGMP, validation, deviations, CAPA, and change control.

Comfortable working directly on the manufacturing floor.

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

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

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

Paid Time Off (PTO): No PTO other than that 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.

Thanks & Regards,

Kunnath Rudra Prasad

Technical Recruiter

Intellectt Inc

Direct:

Desk number: Ext: 189