Sr. C&Q Packaging Equipment Engineer - Ohio

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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:

Email:
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