Laboratory equipment Validation Specialist
LAB EQUIPMENT VALIDATION SPECIALIST
PQE Group is a Contract Quality Organisation and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 9,000 projects worldwide and now serve our Clients from offices in Italy, Spain, Switzerland, Germany, Belgium, Poland, LATAM, USA, the Middle East, China, India & Japan. As an international group we have experience working in more than 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities. PQE Group offers turn key quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for our Clients.
Work to support laboratory quality and technical systems including Lab Equipment Qualification, Data Management and Quality Assurance, collaborating with Facility, Quality Assurance, and Vendors as necessary in the execution and fulfilment of duties. Perform work in accordance with Good Laboratory Practice (GLP).
We are currently looking for a Lab equipment validation specialist based in Boston.
Essential Duties & Responsibilities
- Perform equipment lifecycle activities and associated deliverables pertaining to laboratory instruments and equipment, including but not limited to the installation, testing, execution of validation activities, calibration, maintenance, change control, retirement activities, the renewal of laboratory instrumentation and equipment service contracts as well as assisting on-site vendor maintenance procedures per contract agreement.
- Schedule maintenance and calibration of lab equipment.
- Maintain the records of calibration. Assist in maintain and monitor equipment and instrumentation data in the computerized maintenance management system up to date.
- Maintain equipment inventory and ensure that preventative maintenance is performed according to the manufacturer’s requirements and Standard Operating Procedures. Maintenance such as; Daily, Weekly, Monthly, Quarterly, Biannual, and Annual
- Maintain laboratory maintenance for environment & facility monitoring.
- Ensuring preventive maintenance is performed according to manufacturer’s requirements and internal Standard Operating Procedures (SOPs).
- Train lab users or other staff on SOP and Work Instructions for equipment use.
- Assist in the drafting of new SOPs, work instruction and the maintenance of existing SOPs related to the departmental activities.
- Assists with (new) instrument validation through statistical analysis of data, troubleshooting, effective implementation of analytical methods and provision of technical information to relevant parties.
Minimum Years of Experience
- 2 years in biotechnology sector with knowledge in GxP and GLP preferred
Skills & Abilities
- Ability to demonstrate practical troubleshooting and technical problem analysis techniques.
- Excellent communication skills; fluent (oral/written) English.
- Proficient in Microsoft software applications: Excel, Word, PowerPoint and Outlook.
- Handles multiple assignments and priorities yet still fulfills all commitments. Readily accepts new responsibilities and adapts well to changes in procedures. Gives appropriate priorities to various work demands.
- Ability to multi-task, setting priorities effectively to produce quality work in a fast-paced professional environment
- A self-directed individual and able to adapt quickly to changes in priorities.
- Working knowledge of laboratory regulations, GxP and /or GLP guidelines
- Working knowledge of laboratory equipment, quality control and validation procedures.
- Full availability to travel domestically up to 60% of the worktime
- US Work authorization
- Full availability to accept temporary relocations in US