Commissioning and Qualification (C&Q) Engineer

Position Summary:

The Commissioning and Qualification (C&Q) Engineer will lead and support the planning, execution, and documentation of commissioning, qualification, and airflow visualization (smoke studies) for pharmaceutical cleanrooms, isolators, and critical HVAC utilities to ensure strict regulatory compliance. The incumbent is also responsible and accountable for the execution of the PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development”.

Key Responsibilities

• Commission,

• qualify, and validate facilities, utilities, and/or equipment in assigned

• projects.

• Assists in authors, revises, reviews, and completes controlled documents

• for CQV projects.

• Assists to review and qualify equipment for commissioning,

• qualification, and validation activities.

• Draft

• and execute commissioning and qualification protocols (URS, DQ, IQ, OQ)

• for pharmaceutical HVAC systems and critical manufacturing utilities.

• Plan,

• record, and analyze airflow visualization studies to verify

• cleanroom laminar flow, containment, and FDA/EMA compliance.

• Inspect

• HVAC systems, perform HEPA filter integrity testing, and verify room

• pressure differentials.

• Author

• validation summary reports, manage change controls, and investigate

• deviations per cGMP, Annex 1, and ISPE guidelines.

• Coordinate

• with Quality Assurance (QA), production, and third-party vendors to

• resolve field punch-list items.

Requirements

• Required Qualifications & Skills

• Bachelor’s

• degree in Mechanical, Chemical, or Process Engineering, or a related

• discipline.

• Minimum

• of 3 to 5 years of hands-on validation or C&Q experience within

• a cGMP/FDA-regulated pharmaceutical facility.

• Experience

• authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.

• Experience developing SOPS, final reports and validation & quality

• policies.

• Has good understanding and complies to cGMPs and CFR21.

• Strategic agility and action oriented with the ability to drive results.

• Technical

• Expertise:

• Direct

• experience executing and documenting cleanroom airflow visualization

• (smoke studies).

• Deep

• understanding of pharmaceutical HVAC systems, air handling units (AHUs),

• and pressure cascades.

• Ability

• to read and interpret P&IDs and architectural drawings.

• Strong

• working knowledge of FDA 21 CFR Parts 210/211, EU GMP Annex 1, and ISPE

• baseline guides.