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Biotech Case Manager Jobs in Ohio (NOW HIRING)

CatalYm GmbH

$136.24 - $158.95/hr

Manage the development and review of trial-related documentation including case report forms ... About us CatalYm is a biotech company based in Martinsried near Munich, developing innovative ...

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Biotech Case Manager information

What is a Biotech Case Manager?

A Biotech Case Manager is a professional who coordinates care and services for patients or clients involved in biotechnology-related treatments, such as gene therapies, biologic drugs, or advanced diagnostics. They serve as a liaison between patients, healthcare providers, insurance companies, and biotech companies to ensure smooth access to complex therapies. Their responsibilities often include patient education, monitoring treatment progress, managing insurance authorizations, and supporting adherence to prescribed therapies. Biotech Case Managers play a critical role in helping patients navigate the unique challenges of advanced biotech treatments, ensuring quality care and positive health outcomes.

What are the key skills and qualifications needed to thrive as a Biotech Case Manager?

To thrive as a Biotech Case Manager, you need a solid background in life sciences or healthcare, strong organizational skills, and experience in patient or client management, often supported by a relevant degree. Familiarity with CRM software, electronic health records, and industry-specific platforms is typical, and certifications in case management or healthcare compliance are valuable. Excellent communication, problem-solving abilities, and empathy are the soft skills that help you build relationships and navigate complex cases effectively. These skills and qualities are crucial for ensuring patients receive appropriate care, maintaining regulatory compliance, and optimizing case outcomes in the fast-paced biotech industry.

What are the main challenges a Biotech Case Manager faces when coordinating care between patients, healthcare providers, and biotech companies?

A Biotech Case Manager often encounters challenges in ensuring seamless communication among patients, healthcare teams, and biotech firms, especially when dealing with complex therapies or clinical trials. Navigating insurance approvals and staying updated on rapidly evolving treatment protocols can also be demanding. Success in this role requires strong organizational skills, adaptability, and the ability to advocate for patients while balancing the interests of multiple stakeholders. Collaboration and clear communication are essential to overcoming these hurdles and providing optimal support to patients.

What is the difference between Biotech Case Manager vs Clinical Research Coordinator?

AspectBiotech Case ManagerClinical Research Coordinator
Required CredentialsHealthcare background, certifications like CCM or case management credentialsResearch-related certifications, clinical trial training
Work EnvironmentBiotech companies, healthcare settings, patient-focusedResearch sites, hospitals, clinical trial environments
Employer & Industry UsageBiotech firms, pharmaceutical companies, healthcare providersAcademic institutions, hospitals, research organizations

Both roles involve patient or participant interaction and require healthcare or research certifications. While a Biotech Case Manager focuses on managing patient cases within biotech or healthcare settings, a Clinical Research Coordinator manages clinical trial processes. They share similar environments but differ in primary responsibilities and certifications.

What are popular job titles related to Biotech Case Manager jobs in Ohio?

For Biotech Case Manager jobs in Ohio, the most frequently searched job titles are:

What job categories do people searching Biotech Case Manager jobs in Ohio look for?

The top searched job categories for Biotech Case Manager jobs in Ohio are:

What cities in Ohio are hiring for Biotech Case Manager jobs?

Cities in Ohio with the most Biotech Case Manager job openings:

Biotech Case Manager jobs near you
Infographic showing various Biotech Case Manager job openings in Ohio as of August 2026, with employment types broken down into 78% Full Time, 11% Part Time, and 11% Contract. Highlights an 78% In-person, and 22% Remote job distribution.

CQV Specialist - Packaging Equipment

Pinnaql

New Albany, OH • On-site

Full-time

Re-posted 22 days ago

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a CQV Specialist - Packaging Equipment whowill support commissioning, qualification, and validation activities for packaging equipment and systems in a biotechnology manufacturing environment. The role ensures that packaging lines are installed, tested, and documented in compliance with GMP, FDA, and internal quality requirements while supporting project schedules and startup activities. This is an onsite opportunity in New Albany, OH.
Key Responsibilities
  • Support commissioning, qualification, and validation (CQV) activities for primary and secondary packaging equipment and systems.
  • Develop, review, and execute commissioning and qualification documentation including protocols such as IQ, OQ, and PQ.
  • Verify installation and operational readiness of packaging equipment including labelers, cartoners, serialization systems, inspection systems, and associated utilities.
  • Coordinate activities with engineering, quality assurance, validation, manufacturing, and vendors to ensure proper startup and qualification of packaging lines.
  • Support protocol deviations, discrepancy resolution, and documentation updates as required.
  • Assist with risk assessments, test planning, and validation strategies in accordance with project and regulatory requirements.
  • Ensure compliance with cGMP, FDA regulations, and company validation procedures.
  • Support FAT/SAT activities, startup, and troubleshooting during commissioning phases.
  • Maintain accurate documentation and support turnover packages for validated systems.

Qualifications
  • Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
  • 5+ years of experience in CQV, validation, or commissioning within pharmaceutical or biotechnology manufacturing environments.
  • 2+ years of experience qualifying packaging line equipment such as fillers, labelers, cartoners, serialization/aggregation systems, vision inspection systems, and case packers.
  • Strong knowledge of cGMP regulations, FDA requirements, and validation lifecycle practices.
  • Experience writing and executing validation documentation (IQ/OQ/PQ, protocols, reports, discrepancies).
  • Ability to work cross-functionally with engineering, quality, operations, and project management teams.
  • Strong technical writing and documentation skills.
  • Experience supporting equipment startup, FAT/SAT, and commissioning activities in a regulated environment.
  • Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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