Responsibilities

Development and execution of CQV testing documentation for HVAC & Clean Rooms for the Sterile Drug product facility.

Responsible for meeting key project deliverables for safety, CQV schedule management and quality of project related documentation/electronic records for HVAC & Clean Rooms assigned.

Responsible for ensuring GMP Clean Rooms, Cold Rooms and HVAC Equipment systems are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations and Global procedures.

Risk Management – Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.

Coordination with vendors & contractors during execution of Commissioning & Qualification documents.

Execution of Environmental Monitoring Performance Qualification (EMPQ) protocols in compliance with site procedures and safety procedures for the SDP manufacturing facility.

Performance of sampling and liaising with the laboratory to support testing of the EMPQ samples.

Review of laboratory data and data analysis.

Deviation management associated with the assigned HVAC & Clean Rooms.

Preparation of validation summary reports



Experience/Skills Required

Demonstratable capacity to implement a project CQV strategy, effectively execute the CQV testing approach for assigned from initiation to completion.

Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with quality focus, on time and within budget.

Experience in CQV of Drug Substance/Drug product sterile manufacturing HVAC & Clean Rooms with integrated automation platforms.

Experience using a digital validation execution system (e.g. Kneat or Valgenesis) is an advantage but not essential.

Strong communication skills both written and oral.

Strong problem-solving & analytical skills.

Ability to work within a cross-functional team.



Qualifications & Experience

Bachelor’s degree in a scientific, technical or engineering discipline

3-5 years of C&Q experience to include both documentation preparation and execution.