System Validation Specialist

6 days ago


Billerica, Massachusetts, United States Sequoia Biotech Consulting Full time

About Us

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Syner-G BioPharma Group and Sequoia Biotech Consulting have come together to form a leading life sciences consultancy, empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations.

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer, and commercial manufacturing process. Our goal is to help our partners streamline operations, enhance quality, and ensure compliance.

Our team recognizes that our employees are our most valuable asset, and we strive to create a positive and engaging work environment that fosters culture, career growth, and development opportunities, financial rewards, leadership, and innovation.

Job Overview

The System Validation Specialist will be responsible for ensuring the integrity and reliability of systems and processes through rigorous testing and validation. This role will utilize technical expertise to develop and execute validation protocols, ensuring compliance with industry standards and regulatory requirements.

Key Responsibilities:

  • Perform equipment qualifications, including commissioning, IQ, OQ, and PQ
  • Travel locally and internationally to serve various clients
  • Write, review, approve, and execute validation protocols
  • Create reports summarizing results and statistics
  • Develop and communicate expectations for quality performance, continuous improvement, and quality systems
  • Assist developers and domain experts in designing, performing, and improving verification tests
  • Ensure the validation program meets GMP, FDA, and ISO regulations
  • Collaborate with cross-disciplinary teams to meet project milestones and end goals
  • Interact with stakeholders and client teams to define needs and achievable solutions and/or justifications for equipment requirements and related validation

Requirements

  • Bachelor's degree in a related life science field
  • 4-7 years of experience within the biotech, pharmaceutical, or medical device industry
  • Willingness to travel up to 75-100% for projects at client sites
  • Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required
  • Validation expertise in Equipment, CSV, Method, and Process - Fill Finish a plus
  • Protocol generation experience of automated production systems, with a concentration of computerized equipment and systems validation
  • Report writing experience IQ, OQ, PQ, and CSV
  • Strong verbal and written communication skills and ability to discuss technical topics with non-technical people desired

Compensation and Benefits

The base pay for this position ranges from $88,423.04/year in our lowest geographic market up to $125,935.84/year in our highest geographic market. Pay is based on several factors, including market location and may vary depending on job-related knowledge, skills, and experience.

We offer an excellent Total Rewards Program, which includes excellent healthcare options, family focus and balance, financial security, tuition reimbursement, and employee recognition programs.



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