Quality and Turnover HVAC Engineer

As a

Quality Controller on a pharmaceutical construction site, the candidate plays a critical role in ensuring that all construction activities meet the stringent quality standards required for pharmaceutical environments.

Reporting to the Site QA/QC Manager, the Quality Controller is responsible for conducting inspections, documenting compliance, and supporting the implementation of the Project Quality Plan (PQP), Site Quality Plan (SQP) and relevant project specifications.

Key Responsibilities

• Report to the Site QAQC Manager
• Perform daily inspections and surveillance of construction activities to ensure compliance with project specifications, industry standards, and regulatory requirements.
• Document and report QA/QC findings, including non-conformances, deviations, and corrective actions.
• Verify that materials are stored and handled according to manufacturer specifications and project guidelines.
• Review installation procedures and ensure adherence to approved drawings and technical details.
• Maintain detailed records of inspections, test results, and quality documentation in alignment with the site-specific QA/QC program.
• Support the resolution of quality issues by coordinating with contractors and site supervisors.
• Assist in verifying compliance with contractual and technical requirements during construction.
• Participate in quality audits and contribute to continuous improvement initiatives.
• Review Contractors’ quality documents, including ITPs, FOK, test protocols, etc., in accordance with the Project Requirements.
• Independent quality control and final sign-off of all HVAC and cleanroom systems, including:
• Air Handling Units (AHUs) for GMP Grades A–D cleanrooms
• HEPA/ULPA filtration systems, terminal filters, safe-change housings
• Ductwork (galvanized, stainless steel, pre-insulated)
• Chilled beams, fan filter units (FFUs), laminar flow units
• Building Management System (BMS) integration for temperature, humidity, pressure cascade, particle monitoring
• Smoke extraction and fire damper systems
• Verify and approve installation against approved drawings, specifications and URS

• Witness and sign-off on

• Duct leakage tests (DW143/ EN 1507/ EN 12237)
• Air flow/ volume measurements, pressure cascade verification
• HEPA filter integrity tests (DOP/ DEHS scan testing)
• Room recovery tests, air change rate calculations
• Temperature & humidity mapping (empty state)
• Review and approve calibration certificates (DAkk S/ISO 17025) for all instruments and sensors
• Ensure full compliance with EU-GMP Annex 1, VDI 2083, DIN EN 16798, DIN 1946-4, ISO 14644-1 to -4
• Manage QORs, NCRs, Punches, and deviations until full closure together with the Turnover Team
• Response to Quality Related queries via RFI (Request for Information) from Contractors
• Maintain detailed records of inspections, test results, and non-conformance reports
• Prepare quality control documentation and reports for internal and external audits
• Ensure compliance with GDP (Good Documentation Practice), GEP (Good Engineering Practice) and traceability of quality records
• Recommend corrective actions or modifications for non-compliant systems or components
• Collaborate with engineering and contractors to resolve quality issues
• Work closely with QAQC managers, engineers, and contractors to ensure quality objectives are met
• Participate in quality meetings and contribute to continuous improvement initiatives
• Prepare daily and weekly QC reports, maintain inspection records, and ensure traceability of documentation

Qualifications & Skills

• Minimum 5 years of QC experience with pharmaceutical or biotech cleanroom HVAC systems (greenfield projects highly preferred)

• Proven knowledge and hands‑on experience with

• EU-GMP Annex 1 (2022) cleanroom requirements
• ISO 14644-1 to -4 (classification, testing, monitoring) / VDI 6022
• EN 1886 Air Handling Units (AHUs) – Mechanical Performance Requirements
• EN 12237 – Ventilation for

Buildings: Ductwork – Strength and Leakage of Circular Sheet Metal Ducts Experience in reviewing and approving air‑flow diagrams, duct pressure test reports, and BMS trend data

• Advantageous (strongly preferred)

• Experience with cleanroom qualification (at‑rest and in‑operation testing)
• Familiarity with BMS platforms (Siemens Desigo, Honeywell EBI, etc.)
• Fluent English (spoken & written); German minimum B1–B2 strongly preferred
• Good skills in MS Office; experience with EIDA is a plus
• Work full‑time on‑site (Monday to Friday)
• Operate effectively in a fast‑paced, dynamic construction environment
• Demonstrate a proactive approach to contractor coordination and quality enforcement
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