Validation Engineer - Sequoia Biotech Consulting
Billerica, MA
About the Job
Company Description
Sequoia Biotech Consulting is a leading life sciences consultancy, dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations. Our multidisciplinary team of scientists, engineers, quality experts, and business professionals specializes in optimizing product development, technology transfer, and commercial manufacturing. Additionally, we equip our partners with the tools, knowledge, and expertise to streamline operations, enhance quality, and ensure compliance.
For more information, visit www.sequoiabiotech.com/.
What you will be doing:
The Validation Engineer will ensure the integrity and reliability of systems and processes through rigorous testing and validation. Utilize technical expertise to develop and execute validation protocols, ensuring compliance with industry standards and regulatory requirements. Leverage deep knowledge of validation methodologies to deliver robust and efficient solutions, supporting the continuous improvement of our operations and products.
Is this job for you?
- Perform equipment qualifications including Commissioning, IQ, OQ and PQ
- Travel both locally and internationally to help 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 validation program meets GMP, FDA, and ISO regulations
- Work with scientists, technicians, engineers, and project management to deliver validated equipment and facilities
- Interact with cross-disciplinary teams in order to meet project milestones and end goals
- Collaborate with key stakeholders and client teams to help define needs and achievable solutions and/or justifications for equipment requirements and related validation
Who you are:
- 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 is strongly desired
We Provide a comprehensive Total Rewards Program not limited to:
- Excellent healthcare options: Medical, vision, prescription & dental
- Family Focus & Balance: Parental leave, flexible time-off and Employee Assistance Program
- Financial Security: 401(k) with employer matching
- Tuition Reimbursement: Continuing education for every season of your career
- Employee Recognition Programs
Compensation
Our compensation reflects the cost of labor across several US geographic markets. 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.
Legal Statement
Sequoia Biotech provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws.