Sr. Validation Engineer - Sequoia Biotech Consulting
Waltham, 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:
Sequoia is seeking a Senior Validation Engineer to lead the development and execution of validation protocols for various processes. The Senior Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.
Is this job for you?
- Lead equipment qualifications including Commissioning, IQ, OQ, and PQ.
- Write, review, approve, and execute validation protocols.
- Create detailed 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, ISO regulations, and Annex 1 requirements.
- Work with scientists, technicians, engineers, and project management to deliver validated equipment and facilities.
- Interact with cross-disciplinary teams to meet project milestones and end goals.
- Collaborate with key stakeholders and client teams to define needs and achievable solutions and/or justifications for equipment requirements and related validation.
- Experience with thermal mapping, assisting or self-performing periodic reviews.
- Implement and validate multiple software systems including FMEA, ERP, MES, EMS, BMRAM, EDMS, LMS, and LIMS.
- Ensure compliance with 21 CFR Part 11 for electronic records and signatures.
- Conduct risk assessments and develop mitigation strategies.
- Provide training and mentorship to junior validation engineers.
- Lead projects and manage project timelines, resources, and deliverables.
- Integrate multiple software systems to ensure seamless operation and compliance.
Who you are:
- Bachelor's degree in a related life science field; advanced degree preferred.
- 7-11 years of experience within the biotech, pharmaceutical, or medical device industry.
- Extensive knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis.
- Expertise in Computer System Validation (CSV) and validation of multiple software systems (ERP, MES, EMS, BMRAM, EDMS, LMS, LIMS).
- In-depth understanding of 21 CFR Part 11 compliance requirements.
- Proven experience in protocol generation for automated production systems, with a focus on computerized equipment and systems validation.
- Strong report writing experience for IQ, OQ, PQ, and CSV.
- Excellent verbal and written communication skills, with the ability to discuss technical topics with non-technical stakeholders.
- Strong leadership and project management skills.
- Ability to work independently and as part of a team in a fast-paced environment.
- Prior knowledge of validation in European regulations, including Annex 1.
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 $106,991.88 yearly in our lowest geographic market up to $152,382.37 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.
