Senior Pharmaceutical Packaging Executive / Packaging Engineer

Job Title: Senior Pharmaceutical Packaging Executive / Packaging Engineer

Job Summary:
Responsible for execution and monitoring of in-process checks during pharmaceutical fill finish and packaging operations on blister and bottle packaging lines. Ensures product quality, GMP compliance, data integrity, and effective handling of nonconformances and complaints within a regulated pharmaceutical manufacturing facility. Requires strong quality judgement and hands-on packaging line experience.

Job Responsibilities:

Execute and monitor in-process checks during filling, sealing, labeling, and packaging operations on blister and bottle packaging lines.

Verify fill volume, seal integrity, closure integrity, labeling accuracy, and visual quality against approved specifications.

Perform line clearance, batch start-up verification, in-process controls, and end-of-batch reconciliation activities.

Identify, document, and escalate nonconformances and deviations observed during packaging operations.

Support complaint investigations by providing packaging process data, batch records, and technical inputs.

Apply sound quality judgement to assess product impact, initiate containment actions, and escalate issues to QA.

Ensure GMP-compliant documentation, following GDP and ALCOA principles.

Support equipment setup, changeovers, and troubleshooting of packaging equipment.

Collaborate with QA, QC, Engineering, and Operations for investigations, CAPA, validation, and continuous improvement initiatives.

Comply with cGMP and EHS requirements, maintaining a controlled pharmaceutical manufacturing environment.

Experience & Qualifications:

Minimum 5 years of hands-on experience in pharmaceutical packaging operations, specifically on blister packaging lines and bottle fill finish lines.

Strong working knowledge of GMP regulations (FDA 21 CFR 210/211, EU GMP).

Proven experience handling in-process controls, nonconformances, deviations, and complaint support.

Experience with batch manufacturing/packaging records and GMP documentation practices.

Demonstrated ability to exercise quality judgement in regulated manufacturing environments.

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Engineering, or a related discipline (or equivalent industry experience).

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