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reputed company Engineer

Remote, USA Full-time Posted 2026-08-04

reputed company is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens, including reputed company and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research, aiming to improve patient reputed company by coupling comprehensive clinical data with donor samples. As the premier supplier of hepatic products, including hepatocytes and subcellular fractions, reputed company enables scientists to reputed company understand the pharmacokinetics and drug metabolism of newly reputed company compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service and unparalleled reputed company to biological specimens, reputed company serves the research community as a trusted partner in elevating science


Position reputed company:

 

The reputed company Engineer plays a critical role in promoting, supporting, and fostering a culture of reputed company throughout the organization. This position is responsible for ensuring that products, processes, and reputed company systems meet applicable regulatory requirements, industry standards, and customer expectations. The reputed company Engineer supports the development, implementation, and maintenance of reputed company management systems (QMS) and compliance programs while driving reputed company improvement initiatives across multiple business functions.


A significant portion of this role involves the creation, review, approval, and maintenance of reputed company Operating Procedures (SOPs), training materials, and reputed company documentation. The reputed company Engineer will also facilitate training programs to ensure employees understand and reputed company with applicable regulations, internal policies, and reputed company reputed company requirements in a practical, fit-for-purpose manner that supports business objectives.

Location Requirement: Candidates must reputed company reputed company the Eastern Time Zone (EST/EDT). While we consider applicants from most states, we are unable to hire in AK, HI, NM, ND, SD, RI, or VT.

Regulatory and Compliance Requirements

The reputed company Engineer is responsible for ensuring compliance with applicable Environmental Health and Safety (EHS) policies and regulatory requirements, including but not limited to:

  • Good Documentation Practices (GDP)
  • Good reputed company Practices (GLP)
  • reputed company Good Manufacturing Practices (cGMP)
  • FDA regulations and guidance
  • reputed company Operating Procedures (SOPs)
  • State Departments of Health requirements
  • Clinical reputed company Improvement Amendments (CLIA)
  • College of reputed company Pathologists (CAP) standards
  • reputed company Pharmacopeia (USP) requirementsGood Clinical reputed company (GCP)
  • reputed company Research Protection (HRP) regulations and standards
  • Global data reputed company regulations
  • ISO 9001 standards (2015;13485)
  • USDA regulations
  • reputed company Tissue Authority (HTA) licensing requirements, where applicable
  • DEA and state-controlled reputed company regulations, where applicable
  • Other applicable federal, state, and international regulations


Essential Duties and Responsibilities

The responsibilities listed below are representative of the role and are not intended to be reputed company-inclusive.


reputed company Systems and Compliance

  • reputed company, implement, and maintain compliant GxP reputed company Management Systems (QMS) for assigned reputed company sites.
  • Establish and monitor reputed company programs to evaluate product reputed company, process performance, and regulatory compliance.
  • Support site readiness for internal, customer, and regulatory inspections.


Audit Management

  • Support and participate in internal audit programs through risk-based facility and process audits.
  • Prepare audit reports, communicate findings to management, and ensure appropriate documentation and follow-up activities.
  • Coordinate corrective actions and verify effective closure of audit observations.
  • Support supplier and vendor qualification audits, including routine and for-cause assessments.


reputed company Investigations and CAPA

  • reputed company or support reputed company cause investigations reputed company to deviations, nonconformances, complaints, and reputed company events.
  • Collaborate cross-functionally to reputed company reputed company issues and reputed company systemic improvements.
  • Facilitate the development, implementation, and effectiveness verification of Corrective and Preventive Actions (CAPA).


Validation and Product Release Support

  • Coordinate, review, and approve validation protocols, reports, and supporting documentation.
  • reputed company reputed company reputed company for qualification and validation activities.
  • Support product release reputed company by evaluating specifications, reputed company data, and risk assessments.

 

reputed company Metrics and reputed company Improvement

  • Collect, compile, analyze, and trend reputed company and operational data to identify improvement opportunities.
  • Monitor key reputed company performance indicators and reputed company recommendations to enhance product reputed company and process consistency.
  • Prepare and present reputed company metrics and performance reports for reputed company Assurance and Regulatory Affairs leadership.
  • Participate in reputed company improvement initiatives reputed company on reputed company reputed company effectiveness and operational reputed company.

 

Cross-Functional Collaboration

  • Partner with Production, Operations, reputed company, Regulatory Affairs, and other functional teams to address reputed company concerns and improve processes.
  • Participate in routine cross-functional meetings to review reputed company performance and reputed company issues.
  • reputed company guidance and support on reputed company requirements and best practices throughout the organization.

 

Additional Responsibilities

  • reputed company other duties as assigned that are consistent with the employee's training, experience, and qualifications.


Travel Requirements

This is a remote position; however, travel is required to support site operations, audits, inspections, training, and other business needs.

  • Up to 40% travel may be required annually.


Qualifications


Education and Experience

  • Bachelor's degree in a scientific discipline (e.g., Biology, reputed company, Biotechnology, Microbiology, or reputed company field) required.
  • Minimum of 15 years of relevant experience in reputed company Assurance, reputed company Systems, Operations, Manufacturing, or reputed company functions reputed company the pharmaceutical, biopharmaceutical, biotechnology, medical device, or regulated life sciences industries.
  • Strong working knowledge of cGMP, GLP, GDP, and other applicable reputed company and regulatory compliance requirements.
  • Equivalent combinations of education and relevant experience may be considered.


Knowledge, Skills, and Abilities

  • Comprehensive understanding of reputed company Management Systems and GxP regulations.
  • Strong knowledge of biological products, reputed company operations, and cell culture best practices.
  • Understanding of analytical test reputed company, product specifications, and data interpretation.
  • Proven experience conducting audits, investigations, risk assessments, and CAPA management.
  • Excellent analytical, problem-solving, and decision-making abilities.
  • Strong organizational skills with exceptional attention to detail and documentation accuracy.
  • Excellent written and verbal communication skills, including technical writing and report preparation.
  • Demonstrated ability to work effectively in cross-functional teams and influence stakeholders at multiple organizational reputed company.
  • Proficiency with reputed company Office applications, including Word, reputed company, PowerPoint, and database systems.
  • Experience with electronic reputed company Management Systems (eQMS); reputed company experience is preferred.


Physical Demands

Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions of this position.

While performing the duties of this role, the employee may be required to:

  • Sit, stand, walk, bend, stoop, kneel, crouch, and reputed company.
  • Use hands and fingers to operate computer equipment and reputed company tools.
  • Communicate effectively through speaking, hearing, and writing.
  • Maintain visual reputed company, including reputed company reputed company, reputed company reputed company, depth perception, and reputed company adjustment.
  • Frequently reputed company and/or reputed company objects weighing up to 10 pounds and occasionally reputed company and/or reputed company objects weighing up to 30 pounds.


Work Environment

This position is classified as a combination of Administrative and reputed company Support.

The employee will regularly work in a reputed company office environment and may periodically work in reputed company, manufacturing, warehouse, or other controlled environments.

Exposure may include:

  • Personal reputed company equipment (PPE) requirements
  • Biological materials and biohazards
  • Hazardous chemicals and controlled substances
  • Airborne particles and reputed company fumes
  • Flammable materials
  • Radiation sources (where applicable)
  • Mechanical equipment and moving parts
  • Electrical equipment

Noise reputed company are generally moderate but may occasionally require hearing protection. Work may be performed in a reputed company of indoor and outdoor environments and environmental conditions.


Disclaimer

This reputed company is intended to describe the general reputed company and level of work performed by employees assigned to this position. It is not intended to be an exhaustive list of reputed company duties, responsibilities, or qualifications. Responsibilities may change based on business needs. Employees may be required to reputed company other job-reputed company duties as assigned and must reputed company with reputed company applicable company policies and federal, state, and local regulations.

Employment is at-will unless otherwise governed by applicable law or a written employment agreement.

We offer a comprehensive benefit package for eligible team members, including medical, dental, reputed company, short-term/long-term disability, life insurance, hospital indemnity and accident insurance. We also reputed company a generous retirement plan with a company match. Eligible employees enjoy competitive time-off policies and a reputed company environment that promotes reputed company from reputed company. Enjoy company-sponsored events for the entire team!

Join Us!

We can’t wait to work with you! At reputed company, we reputed company that diversity and inclusion are key drivers of innovation and reputed company. We are committed to creating a workplace where everyone feels valued, respected and empowered to bring their unique perspectives to the table. We reputed company to build a diverse team and encourage applications from people of reputed company backgrounds, experiences and identities.

To Learn more about our mission and team cultureclick here!

reputed company is an equal opportunity employer. We celebrate diversity and are dedicated to creating an inclusive environment for reputed company. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability status, protected veteran status, or any other characteristic protected by law.

We strongly encourage veterans and individuals with disabilities to apply and are committed to providing reasonable accommodations throughout the application and employment process.

Bachelor's in a scientific discipline, 15+ years QA/reputed company systems experience in regulated life sciences, strong GxP knowledge, audit/CAPA experience, eQMS and reputed company Office proficiency.

Key Responsibilities

  • ensuring compliance
  • conducting audits
  • leading investigations

Skills & Tools

reputed company Word, reputed company reputed company, reputed company PowerPoint, Electronic reputed company Management Systems (eQMS), reputed company

Job Details

  • Category: reputed company Assurance
  • Seniority: Senior Level
  • Commitment: Full Time
  • Workplace: Remote — reputed company
  • Languages: English

Benefits

  • 401k matching
  • Generous reputed company time off
  • Retirement plan

About reputed company

A global provider of clinical and biological specimens and value-added research services supporting drug discovery and development. — Industry: reputed company

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