Sr. C&Q Packaging Equipment Engineer

Role: Sr. C&Q Packaging Equipment Engineer
Location: Ohio
Interview Mode: Skype
Can do Only W2 No C2C

Job Description:

We are seeking an experienced Sr. C&Q Packaging Equipment Engineer to support commissioning qualification and startup activities for pharmaceutical packaging equipment and systems. The ideal candidate will have strong experience in GMP-regulated pharmaceutical or biotech environments and hands-on expertise with packaging equipment validation and startup activities.

Responsibilities:

• Lead commissioning and qualification activities for pharmaceutical packaging equipment.
• Execute and review IQ/OQ/PQ protocols for packaging systems.
• Support startup and operational readiness of packaging lines.
• Work on packaging equipment such as labeling cartoning serialization inspection and case packing systems.
• Develop and review validation lifecycle documents protocols traceability matrices and summary reports.
• Support FAT and SAT activities with vendors and system integrators.
• Troubleshoot equipment and process issues during startup and qualification phases.
• Ensure compliance with GMP FDA and global regulatory requirements.
• Participate in risk assessments FMEA activities deviations CAPAs and change controls.
• Collaborate with Manufacturing QA Automation Maintenance and Engineering teams.
• Drive continuous improvement initiatives for packaging line efficiency and compliance.

Required Skills:

• Strong experience in Commissioning & Qualification (C&Q).
• Pharmaceutical/Biotech packaging equipment experience.
• IQ/OQ/PQ execution and documentation.
• GMP and FDA compliance knowledge.
• FAT/SAT experience.
• Validation lifecycle documentation.
• Packaging line startup and troubleshooting.
• Experience with serialization labeling cartoning inspection and case packing systems.
• Knowledge of change control CAPA and deviation management.
• Strong communication and coordination skills.

Preferred Qualifications:

• Experience in Biotech or Pharmaceutical manufacturing environments.
• Familiarity with risk assessments and FMEA.
• Ability to work independently in fast-paced project environments.

Best Regards:

Emma W
Phone: 1-
Email: