Job Description

About the role:

Anter is seeking an experienced and highly motivated Senior HVAC Engineer to provide end-to-end support for our pharmaceutical client's in SIngapore. This role is critical in ensuring all new and modified HVAC systems meet stringent regulatory, Good Manufacturing Practice (GMP), and design requirements from initial concept through final operational handover.

Key Focus Areas: End-to-End CQV Lifecycle

Design & Planning (DQ):

Act as the HVAC Subject Matter Expert (SME), ensuring design adheres to cGMP/GEP and ISPE Baseline Guide 5 (HVAC).


Review and approve core engineering documents: P&IDs, specifications, User Requirements Specifications (URS), and Functional Requirements Specifications (FRS).


Lead and document Quality Risk Assessments (e.g., FMEA) to define the scope of qualification.
Commissioning & Testing (C):

Develop detailed Commissioning Test Procedures (CTP) for AHUs, cleanroom controls, and pressure cascades.


Oversee and execute functional testing and Integrated System Testing (IST) in the field.


Manage and resolve deviations and punch list items efficiently for system turnover.
Qualification & Validation (Q/V):

Author, review, and execute Qualification Protocols (IQ/OQ/PQ) for HVAC and cleanroom environments.


Coordinate and execute crucial tests like temperature/humidity mapping, room pressure differential testing, and HEPA filter integrity (DOP/PAO) testing.


Generate formal Qualification Summary Reports to document successful compliance and system release.
Compliance & Documentation:

Ensure all CQV activities strictly follow cGMP, ASTM E2500, and regulatory guidelines (FDA, EMA).


Support the Change Control process for any system modifications throughout the project.


Manage the compilation and archival of the final Turnover Package (TOP).

Essential Requirements & Qualifications

Experience:

Minimum 7+ years of dedicated experience in CQV within the pharmaceutical or biotech industry.


Proven hands-on experience executing HVAC-specific IQ/OQ/PQ protocols for cleanrooms.


Experience working on large-scale capital expansion projects is mandatory.
Education:

Bachelor's Degree in Mechanical Engineering, Chemical Engineering, or a related field.
Technical Skills:

Expert knowledge of cGMP regulations as applied to critical utility systems like HVAC.


Strong ability to interpret P&IDs, airflow diagrams, and Control Narratives.


Familiarity with Building Management Systems (BMS)/automation used in GMP environments.
Soft Skills:

Excellent written and verbal communication skills for protocol and report writing.


Demonstrated ability to troubleshoot complex HVAC and control issues.


Effective stakeholder management and ability to interface with QA, Engineering, and Operations teams.