6541 - Lab Technician / Validation Engineer

Lab Technician Responsibilities:

• Develop and maintain knowledge of applicable regulations and requirements.
• Provide Quality Control (QC) support for the QC laboratory.
• Implement, maintain, and /or enhance appropriate quality systems within QC laboratory.
• Author, maintain, and instruct on on-the-job courses for laboratory equipment, testing inspection, and laboratory operations.
• Perform and oversee QC laboratory equipment setup, operation, and maintenance.
• Build and maintain working relationships with multiple functions and Contract Manufacturers supporting batch release testing
• Participate in new product design and pre-launch preparation projects to support laboratory operations and device testing.
• Participate in departmental process improvement activities.
• Maintain laboratory inventory management.
• Assist in equipment qualification testing activities including IQ, OQ, and PQ.
• Maintain and manage the reference sample retention area.
• Support and perform laboratory device testing for commercial and development product using good documentation practices.
• Perform test equipment setup, operation, and maintenance.
• Support shipping and receiving activities as assigned.
• Create /Edit lot release workshops as needed.
• Maintain laboratory notebooks, including authoring, revision, and retirement
• Participate in regulatory agency and internal inspections.
• Ensure that all test equipment is properly validated and maintained for its intended use.
• Support Event Management through roles of originator and executor of deviations impacting the QC laboratory, including origination of SARE as appropriate.
• Support Change Management through roles of originator and /or executor of tasks and implementation steps.

Requirements:

• Minimum of 3-5 years of regulated industry experience with demonstrated knowledge of related quality systems and regulatory requirements (e .g., cGMP, 21 CFR 820, ISO 13485, ISO 194971, Canadian MDR, EU Medical Device Directive, JPAL )
• Strong problem solving and analytical thinking skills
• Strong verbal and written communication skills in English.
• Self-management / motivated.
• Demonstrated techComputer literate in Outlook, Windows and Microsoft applications
• Excellent teamwork and abilitiy to multi-task.
• Strong curiosity skills with the ability to question /identify issues and work to resolution.
• Strong critical thinking /problem solving skills with an ability to apply rationale.

Additional Preferences:

• Three years experience in Quality or TS /MS support.
• Attention to detail.
• Experience with Microsoft Office Suite
• Above average computer literacy and computer skills – specific training relating to software used will be provided.
• Demonstrated knowledge and application of federal regulations as applicable to the pharmaceutical industry and related quality systems.
• Ability to mentor /train others – share learning.