Columbus, Ohio, United States · On-site
Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biote…
Skills: Aseptic Process Simulation, Media Fill, Process Validation, Contamination Control, Risk Assessment
Columbus, Ohio, United States · On-site
Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biote…
Skills: Manufacturing Science & Technology, Process Engineering, Technology Transfer, Process Validation, Root Cause Analysis
Columbus, Ohio, United States · On-site
Certified Group is committed to partnering with customers to deliver innovative scientific solutions and expertise – So The World Can Trust In What It Consumes™. Our network of 30+ North American and European laboratorie…
Skills: Instructional Design, Coaching, Technical Training, Competency Assessment, Curriculum Development
Columbus, Ohio, United States · Remote OK
$182k–$217k/yr
The Regional Business Director (RBD) will be a critical member of the Sales Leadership team, reporting directly to the VP, Sales, and will be responsible for developing and executing the region’s business strategy to del…
Skills: Sales Leadership, Business Strategy, Coaching And Development, Performance Management, Rare Disease Market
Columbus, Ohio, United States · On-site
$22/hr–$23/hr
KDC is a network of best-in-class custom formulators and manufacturers of color cosmetics, skincare, haircare, bath & body, fragrance, deodorant, home, health, industrial, and auto care products. KDC delivers high-touch …
Skills: Stability Testing, Sample Tracking, Laboratory Documentation, Viscometer, Ph Meter
Columbus, Ohio, United States · On-site
Overview: Schedule: Full Time, 8am - 4:30pm, weekend and holiday rotation, Benefits Eligible Job Description Summary: Provides clerical and patient care support, especially regarding specimen collection and specimen proc…
Skills: Specimen Collection, Phlebotomy, Specimen Accessioning, Laboratory Testing, Patient Registration
Columbus, Ohio, United States · On-site
$183k–$290k/yr
MSL or Senior MSL – Hematology (Ohio) Are you ready to move in and join an amazing team? Do you have expertise in, and passion for Medical Affairs in Oncology? Are you ready to make a significant impact in the field of H…
Skills: Medical Affairs, Hematology, Oncology, Scientific Exchange, Clinical Trial Methodology
Columbus, Ohio, United States · Hybrid
$80k–$95k/yr
Your Future as a BCBA Starts Here—And It’s Looking Bright Join the largest female clinician-led ABA agency in the country and work with people who just get it. At Autism Learning Partners, we’re all about growing togethe…
Skills: Applied Behavior Analysis, Supervision, Functional Behavior Assessments, Program Development, Parent Education
Columbus, Ohio, United States · On-site
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact [email protected]. If you have questions while submitting an application, please review these frequ…
Skills: Teaching, Precepting, Public Health, Community Pharmacy Collaboration, Project Planning
Columbus, Ohio, United States · On-site
$51k–$101k/yr
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnost…
Skills: Packaging Testing, AutoCAD, SolidWorks, Cape Pack, Validation Protocols
Columbus, Ohio, United States · On-site
$81k–$97k/yr
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact [email protected]. If you have questions while submitting an application, please review these frequ…
Skills: Teaching, Organic Chemistry, Curriculum Implementation, Syllabus Preparation, Student Evaluation
Columbus, Ohio, United States · Hybrid
$140k–$183k/yr
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact [email protected]. If you have questions while submitting an application, please review these frequ…
Skills: Export Control, National Security Compliance, Risk Assessment, Strategic Planning, Staff Supervision
Columbus, Ohio, United States · Hybrid
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact [email protected]. If you have questions while submitting an application, please review these frequ…
Skills: Clinical Trials Design, Biostatistics, Protocol Development, Randomization Schemes, Sample Size Methods
Columbus, Ohio, United States · On-site
We are more than a health system. We are a belief system. We believe wellness and sickness are both part of a lifelong partnership, and that everyone could use an expert guide. We work hard, care deeply and reach further…
Skills: Complex Analysis, Quality Control, Instrument Maintenance, Troubleshooting, Customer Service
Columbus, Ohio, United States · On-site
Adjunct Instructor, Philosophy The Columbus College of Art & Design (CCAD) is seeking a Part-Time Adjunct Instructor for our Writing, Literature and Philosophy Department to teach Introduction to Philosophy. Introduction…
Skills: Philosophical Thinking, Critical Thinking, Expository Writing, Critical Analysis, Hermeneutics
Columbus, Ohio, United States · On-site
$116k–$167k/yr
Otsuka America Pharmaceutical Inc. is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets in…
Skills: Pharmaceutical Sales, Territory Analysis, Business Planning, Account Management, Strategic Relationship Building
Columbus, Ohio, United States · On-site
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact [email protected]. If you have questions while submitting an application, please review these frequ…
Skills: Patient Recruitment, Informed Consent, Clinical Data Collection, Regulatory Compliance, Biological Sample Processing
Columbus, Ohio, United States · On-site
$62k–$65k/yr
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact [email protected]. If you have questions while submitting an application, please review these frequ…
Skills: Statistical Programming, Data Analysis, R, Python, Matlab
Columbus, Ohio, United States · Hybrid
$56k–$73k/yr
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact [email protected]. If you have questions while submitting an application, please review these frequ…
Skills: Financial Administration, Budget Monitoring, Program Management, Event Coordination, Procurement
Columbus, Ohio, United States · On-site
Screen reader users may encounter difficulty with this site. For assistance with applying, please contact [email protected]. If you have questions while submitting an application, please review these frequ…
Skills: Craniofacial Biology, Immunology, Microbiology, Scientific Publishing, Grant Writing
Columbus, Ohio, United States • On-site
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The Senior Validation SME is responsible for developing and managing the Aseptic Process Simulation (APS) strategy and media fill program to ensure sterile manufacturing compliance. This includes planning studies, investigating deviations, and collaborating with cross-functional teams to maintain high-quality product standards.
Requires a degree in Life Sciences or a related field with 5-8 years of experience, including at least 3 years in commercial drug product filling. Candidates must possess deep expertise in aseptic processing, GMP regulations, and risk assessment within biologics or gene therapy manufacturing.
Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.
Tunnell Consulting, looks for top consultants on behalf of our Pharmaceutical/Biotech clients. Currently, one of our client’s needs a Senior Validation SME - Aseptic Process Simulation. This is a 3-6 month contract role. Work to be performed Onsite. Client is based in the Greater Columbus, OH area.
The Senior Validation SME is responsible for improving the company's Aseptic Process Simulation (APS), or Media Fill, program. This role develops and manages strategies, validation plans, and testing methods to ensure sterile manufacturing processes consistently meet regulatory and quality requirements.
The position works closely with Manufacturing, Quality Assurance, Engineering, Microbiology, and other teams to plan, execute, analyze, and continuously improve media fill studies. The specialist also serves as the primary contact for regulatory agencies regarding aseptic process simulation activities.
Additionally, the role supports process validation programs to ensure manufacturing processes are reliable, compliant, and capable of consistently producing high-quality products.
General Expectations
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
Impacting humankind and solving the most complex problems in life sciences.
With a strong focus on the life sciences industry, Tunnell Consulting designs and implements sustainable solutions that improve the operating performance of each unique client we serve. Integrating technical, process and organizational skills, our proven problem-solving methodologies enable life science companies to achieve optimal compliance and quality performance, operational excellence and organizational effectiveness. Since our founding in 1962, our experienced professionals, representing a wide range of scientific, technical, analytical and business disciplines, have worked with leading life sciences companies to achieve increased efficiency and measurable results that show up on the top and bottom lines. Our capabilities include: Cost Reduction, Operational Excellence, Business Transformation, Process Understanding, QbD, Technology Transfer, Quality and Regulatory Compliance and much more. The greatest measure of our success continues to be the high percentage of clients who repeatedly return to us when they expand, reorganize or encounter an organizational obstacle.
Offices: 1235 Westlakes Dr, 280, Berwyn, Pennsylvania 19312, US
There are currently 513 open science & research positions in Columbus, OH listed on Clera. New openings are added daily as companies post roles.
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