Validation Engineer
1 week ago
Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum.
We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form 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.
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. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance.
Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.
At Syner-G and Sequoia, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
For more information, visit www.Sequoiabiotech.com/ or www.Synergbiopharma.com
What you will be doing:
Sequoia is seeking a Validation Engineer to assist with the development and execution of validation protocols for various types processes. The 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?
- Generates and executes life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes for (re)qualification/(re)verification.
- Supporting validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR).
- Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
- Writes reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
- Writes procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments
- Performs P&ID Walkdowns. Performs Thermal mapping of temperature controlled chambers, warehouses, and SIP processes.
- Supports the resolution of regulatory observations or manufacturing site issues.
- Executing periodic reviews and requalification for temperature chambers.
- Bachelor's degree in a related life science field
- 4-7 years of experience within the biotech, pharmaceutical or medical device industry
- Knowledge and experience working with FDA cGMP, FMEA and Risk Analysis required
- Validation expertise in Equipment, CSV, Method, and Process
- 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
- 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 yearly in our lowest geographic market up to $125,935.84 yearly 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
Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.
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