Posted: 11/27/20242024-11-272025-01-04Employment Type:Direct Hire/PermJob Category:LIMSJob Number: 625696Is job remote?: NoCountry: United States
Job Description
Sr. Lab Specialist (Validation & Instrumentation) – (Perm/Contract) – Onsite – OH
Pharmaceutical organization seeks a Sr. Lab Specialist with a history working within Validation and instrumentation for an onsite Permanent or Contract Opportunity. Ideal candidate will have 4+ years’ experience in laboratories, lab instrumentation and validation. Some Project Management and regulatory GMP expertise relating to lab instrumentation are also required. This individual will oversee the Calibration and Validation Programs as well as conduct instrumentation repair and maintenance, with some project management of capital projects. Opportunity affords the qualified candidate a position with competitive base compensation, bonus incentive, benefits and more.
Requirements
BA/BS Degree in IT or Computer Science
Laboratory Background, Instrument Validation and Lab IT Experience.
Expertise and proven history in Project Management.
4+ years systems experience to LIMS, QMS, LES, SDMS and others; LabWare is a plus.
A history working within Life Sciences or specifically Pharmaceutical to assist in compliance, maintenance, lab instrumentation repair and other related documentation.
Extensive knowledge in regulatory environments related to lab instrumentation calibration, cGMP regulations, as well as training and certification.
Ideally local to Ohio or immediate surrounding areas, with the ability to go onsite weekdays.
Strong skills in working collaboratively within a team dynamic, while liaising cross-functionally as needed across multiple areas of the organization.
Responsibilities
Overseeing the Calibration and Validation Programs while also conducting instrumentation repair and maintenance and project managing capital projects.
Performing compliance, maintenance, and repair of lab instrumentation within a team environment to include authoring and updating related documentation.
Mentoring junior level talent to include performing training and assisting regularly on troubleshooting and improvement of individual performance and techniques.
Ongoing communication with service engineers and Quality Lab Management personnel to drive the identification of root causes for instrumentation failures through internal impact assessment process.
Communicating regularly with flow lanes, QA, and Compliance to document and complete CAPAs.
Reviewing vendor calibration documentation as needed.
Performing peer reviews for all instrumentation calibration and training certifications ensuring these are initiated accordingly and impeccably.
Utilization of scientific knowledge of analytical chemistry and instrumentation to perform calibrations within assigned areas.
Reviewing GMP, Laboratory, and Equipment Change Controls regularly.
Initiating and coordinating instrument validation process, while also reviewing validation protocols which include IQ, OQ, PQ, and VAPR.
Working within Validation and Quality Assurance for approval of Validation Plans.
Coordinating with lab management and IT for protocol execution and with laboratories for the review of instrumental needs.
Liaising with upper management regarding budget based on approved capital.
Working with Engineering for service needs and infrastructural requirements.
Reconciling asset processes with Finance and Disposing of assets at the lifecycle’s end.
Ensuring instrument training is purchased and facilitated as needed.
Assisting with instrumentation repairs and maintenance to include liaising and coordinating with individuals, teams, maintenance department or 3rd party engineers.
Responsible for maintaining and scheduling calibrations within database.
Communicating directly with service engineers while properly setting expectations.
Performing troubleshooting to enable labs to meet release requirements.
Developing ROI investment calculation for various repairs involving costly or repetitive.
Serving as area support person for Analytical Development, QC and Launch Analytics.
Coordinating/managing departmental work instruction, while identifying those requiring updates based on new processes, instrumentation or regulations.
Coordinating with management for content while ensuring timelines are met.
Communicating with scientists to ensure buy-in for procedural updates.
Building consensus with QLABS, AD, Managers, and Analysts for procedural harmonization.
Identifying opportunities for improvement of lab instrumentation.
Driving cost savings within the laboratory through regular review of instrument and service quotes.
Benefits
Competitive Base comp depending upon the seniority of the individual.
Full health, dental and vision benefits.
401K employer match of up to 6%
23 vacation/personal days
11 paid company holidays
Tuition Reimbursement
Maternity and Parental Leave
Career advancement and growth opportunities.
Annual Merit Increase of up to 4%.
10% performance-based annual bonus.
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Planet Technology and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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