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Validation Engineer - facilities & utilities

Pharmaceutical company based in Austin, Texas are currently seeking a Validation Engineer to join the facilities and utilities engineering team for a direct hire permanent role. As the Validation Engineer you will be responsible for qualification & validation development and execution of various systems such as: HVAC & the associated controls system (metasys), compressed air systems, purified water systems, water for injection systems (reverse osmosis system, WFI stills and distillation stills), clean steam, nitrogen systems

All the systems have electronic controls systems associated to them, such as PLC and HMI automation systems.

You will be based in a sterile cleanroom pharmaceutical manufacturing facility.

Responsibilities:

* Develop Validation Plans, ensuring strategies are in alignment with validation policies, procedures and external regulatory requirements and guidance's. As appropriate develop and maintain an annual plan of sterilization requalification and periodic reviews to be completed during each calendar year. Reporting on progress as required.

* Write and execute validation documents (IQ, OQ, IOQ, PQ etc.) compliant with plant policies and procedures. Proactively identifying risks/issues and completing risk assessments as necessary.

* Initiate and author validation assessments and validation gap analysis as required.

* Plan and lead revalidation of existing plant sterilization equipment.

* Review validation documentation.

* Own investigations in the event of failures or adverse trends; identify root cause, determine and complete corrective/preventative actions. Expected to seek subject matter experts (SME) and bring validation expertise, strong analytical and systematic problem solving skills.

* Assess change controls; perform impact assessment based on knowledge of process and validation principles and policies.

Requirements:

  • 2 years of facilities & utilities validation experience in a pharmaceutical/sterile cleanroom environment.
  • Bachelors Degree

If you are interested and meet the requirements, please apply with your resume and Real Staffing will reach out to discuss the details of the company and role further.

The salary is circa $85K + bonus and relocation package n offer.

Sthree US is acting as an Employment Agency in relation to this vacancy.