Skip to content

Job Openings

So sorry, that position has been filled. Please go ahead and submit your application. We may have other positions that would be the perfect fit for you. Alternatively, you may want to apply to one of the following related jobs:

Sr. Lab Specialist (Validation/Instrumentation)

Columbus, OH 43236

Posted: 11/27/2024 Employment Type: Direct Hire/Perm Job Category: LIMS Job Number: 625696 Country: United States Is job remote?: No

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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet domain (@theplanetgroup.com, @theplanetforward.com, @planet-technology.com, @planet-pro.com, @planetinteractive.com, @pfes.com, @launchcg.com, @planet-pharma.com, @planet-healthcare.com) - and not a domain with an alternative extension like .net, .org or .jobs.

The Planet Group and our 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.

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

About Columbus, OH

Ready to embark on an exciting career journey in the vibrant Columbus, Ohio area? Known for its thriving job market, outstanding quality of life, and abundance of opportunities for professional growth, this city beckons with its infectious energy and welcoming community. Home to the renowned Columbus Museum of Art, the historic Ohio Theatre, and the beloved Columbus Blue Jackets hockey team, this region seamlessly combines art, culture, and sports to create a dynamic environment that caters to diverse interests. With delectable cuisine, picturesque parks like the beautiful Franklin Park Conservatory and Botanical Gardens, and a bustling downtown scene, Columbus is a destination brimming with charm. Take the first step towards your dream job today by exploring our job listings in this lively and enchanting locale.
Social Share Buttons and Icons powered by Ultimatelysocial