Sr. Validation Engineer

As a Sr. Validation Engineer at Forge Biologics, your responsibilities will encompass developing and executing validation protocols, including installation, operational, and performance qualifications for manufacturing equipment. You’ll collaborate closely with various cross-functional teams to ensure the effectiveness and compliance of our operations. Additionally, you’ll lead investigations related to deviations and non-conformances, conduct hands-on validation activities, and mentor junior engineers, fostering a collaborative and knowledge-sharing environment.

To qualify for the Sr. Validation Engineer role at Forge Biologics, candidates should typically possess a Bachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or a related field, along with significant experience in equipment validation within the pharmaceutical or biotechnology industry. You’ll also need to demonstrate proficiency in risk assessment methodologies and a strong understanding of Good Manufacturing Practices (GMP), as well as excellent communication and project management skills.

At Forge Biologics, the culture for a Sr. Validation Engineer is rooted in collaboration, innovation, and purpose-driven work. The company champions values like hard work, openness, and engagement. You'll be part of a diverse team of passionate individuals dedicated to solving complex challenges in gene therapy, fostering an environment that encourages creativity, professional development, and a shared mission to enhance patient outcomes.

At Forge Biologics, career development as a Sr. Validation Engineer is taken seriously. The company offers numerous professional and personal development resources, including access to LinkedIn Learning, mentoring opportunities, and leadership development coaches. You’ll have the chance to enhance your skills, take on new challenges, and grow your career while actively contributing to meaningful work in gene therapy.

Expected outcomes for a Sr. Validation Engineer at Forge Biologics include successfully developing robust validation protocols that ensure compliance with regulatory guidelines, facilitating timely and effective validation activities across multiple projects, and implementing effective corrective and preventive actions in response to validation-related issues. The role aims to enhance manufacturing processes and contribute to the overall mission of delivering innovative gene therapies.

When answering this question, highlight your specific experiences with equipment validation, including types of equipment you’ve qualified and the protocols you’ve developed. Mention any relevant regulatory guidelines you’ve adhered to and challenges you overcame during validation projects.

To ensure compliance, I meticulously develop validation protocols aligned with FDA, EMA, and industry standards. I emphasize thorough documentation, perform comprehensive risk assessments, and maintain open communication with cross-functional teams to ensure all activities meet the required standards.

Use the STAR technique to discuss a specific instance of a deviation, explaining the situation, your actions, and the results. Focus on your problem-solving process, detail how you conducted investigations, and emphasize learning outcomes that improved future validation processes.

Common challenges include keeping up with evolving industry standards, managing project timelines, and ensuring proper cross-department collaboration. I approach these challenges with proactive planning, strong stakeholder communication, and continuous education on regulatory updates and industry best practices.

I prioritize projects based on urgency, strategic importance, and regulatory deadlines. I utilize project management tools and maintain regular communication with teams to ensure alignment and address any potential roadblocks, allowing for efficient and timely execution.

I typically employ risk assessment methodologies like FMEA (Failure Mode and Effects Analysis) and FMECA (Failure Mode, Effects, and Criticality Analysis). I focus on identifying potential failure points during the validation process and developing appropriate controls to mitigate those risks effectively.

I consistently engage in professional development by attending industry conferences, participating in webinars, and reading relevant publications. Networking with peers and following regulatory agency updates also plays a vital role in keeping my knowledge current.

Documentation is crucial in validation as it provides evidence of compliance and quality. I ensure that all protocols, results, and deviations are thoroughly documented, facilitating transparency, training of junior staff, and readiness for regulatory audits.

Certainly! At my previous job, I implemented a feedback loop system to regularly assess and improve validation protocols. By collaborating with cross-functional teams, we identified areas for efficiency gains and successfully revised processes that led to reduced validation time and improved compliance.

Essential soft skills include strong communication for effective collaboration, problem-solving to address challenges proactively, and project management to handle multiple tasks efficiently. Additionally, being adaptable and open to feedback fosters a positive team environment and continuous improvement.