Job Description

HiTech Health focuses on enabling healthcare companies to develop, launch and supply products to the market. The company was established in 2013, bringing together an experienced and multi-disciplinary team from across the pharmaceutical, biotechnology and medical device industries. Operating internationally, HiTech Health supports pharmaceutical and biopharmaceutical companies, as well as sterile medicinal product developers, to develop, manufacture and supply life-changing therapies to patients

Due to continued growth, HiTech Health are seeking to hire a GMP Cleanroom Operator for our GMP manufacturing facility in Galway. This is an on-site, permanent position based at our Galway facility. The successful candidate will support the day-to-day operation of the GMP manufacturing facility, with a primary focus on cleanroom manufacturing activities and associated GMP operations. The role will also provide support to routine microbiological and environmental monitoring activities within the facility.

This is a hands-on position suited to an individual with practical experience working within a GMP cleanroom environment and a strong understanding of aseptic practices, contamination control and Good Documentation Practice.

Responsibilities:

• Perform routine aseptic manufacturing activities and associated operational activities within GMP cleanroom environments.
• Prepare, transfer and stage materials, equipment and consumables required for manufacturing activities.
• Perform cleaning and disinfection activities within classified areas in accordance with approved procedures.
• Complete GMP documentation accurately and contemporaneously, including batch records, logbooks, checklists and associated manufacturing records.
• Perform routine microbiological support activities including environmental monitoring sampling, incubation and reading of microbiological plates, colony enumeration and recording of results.
• Assist with microbiological sampling, testing and laboratory activities where trained and required.
• Support receipt, inspection, storage and movement of GMP materials and consumables.
• Support investigations, corrective and preventive actions and continuous improvement activities where required.
• Work closely with Manufacturing, Quality and QC personnel to support the effective day-to-day operation of the GMP facility.

Essential Requirements:

• Minimum 2 years’ practical experience working within a GMP cleanroom or sterile manufacturing environment.
• Practical understanding of GMP requirements and Good Documentation Practice.
• Experience performing routine cleanroom operations and working in accordance with controlled procedures.
• Understanding of aseptic technique and contamination control principles.
• Ability to follow detailed procedures and work effectively within a regulated manufacturing environment.
• Strong attention to detail and a quality-focused approach to work.
• Good written and verbal communication skills.

Salary Range: Negotiable. Salary is commensurate with experience and overall suitability for the position.

Working hours: Normal working hours will be Monday – Friday, 37.5 hrs per week.

Location: HiTech Health operations are based in Galway.  This is an on-site position.

Start date: To be confirmed – subject to successful candidate’s notice period.

To Apply:

Please email your CV to jobs@hitech-health.com referencing the job role in the subject line.

We reserve the right to re-advertise or extend the closing date for this job post.

HiTech Health is an equal opportunities employer.