We are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking for an inspired environment, passionate colleagues, and a culture that nurtures learning, innovation and team success, we invite you to join us.
The Role:
The Validation Engineer II reports to the Associate Director, Quality Engineering & Validation. The Validation Engineer II is responsible for the application of the Agenus risk-based approach to qualification and validation of manufacturing and laboratory equipment and computerized systems used to ensure cGMP/Part 11 compliance and support operations with continuous process improvement in maintaining equipment and regulated software in a qualified and/or validated-state.
In the role you will:
Generate, support, and/or execute commissioning and qualification/validation deliverables as per Agenus procedures, such as, but not limited to: validation plans, user’s requirements, functional specifications, requirements traceability matrices, protocols (FAT, SAT, IQ/OQ, PQ) and final reports summarizing testing activities and deviations across a wide variety of equipment, utilities and lab instrumentation systems used in the biopharmaceutical industry. Develop qualification/validation schedules for startup of new, modified, and existing facilities, equipment, and systems. Maintain inspection readiness of equipment and computerized system validation documents, including tracking and archiving of validation documents. Contribute to and review change controls, deviations, investigations, CAPAs, and risk assessments. Contribute to the generation, review, and approval of system design documentation, including Design Specifications, System P&IDs, System Impact Assessments, Functionality Assessments, and Component Criticality Assessments. Support the implementation of the Validation Periodic Review Program. Provide facilities, utilities, and equipment validation data for quarterly management reviews and for batch summaries.Qualifications: About You
Experience with current US and international regulations, guidance, and industry best practices in the following areas of validation: startup, commissioning and qualification, equipment, and computerized systems validation. Experience with process validation is a plus. 8+ years in related work experience in a biotechnology and/or pharmaceutical GMP manufacturing environment. Requires a minimum B.S. degree in Engineering (e.g., Mechanical, Electrical, Computer, Chemical or Biomedical) or related discipline. Any additional certifications are a plus (e.g., ASQ-CQA, CQE, CSQE, among others). Must possess good interpersonal, communication and team skills. Strong focus on quality. Basic understanding and working experience in the development of GMP documentation to support the qualification and validation of GMP equipment and systems. Familiarity with the basics of metrology. Experience in technical writing: (e.g. protocol generation and report authoring). High execution: Demonstrates and fosters a winning mind set, a sense of urgency, optimism, and ownership, and a strong drive to achieve goals and organizational success. Collaboration: Demonstrated ability to work cross-functionally, manage crises and align interests of multiple parties. Detail Orientation: Ability to bring laser focus and attention to detail to critical projects, comfort operating “in the weeds” without losing sight of the big picture, aptitude for mastering operational specifics of each project to facilitate its efficient advancement.#LI-JW1
The targeted salary range for this position is 80,000-113,400 per year. Agenus is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offered is commensurate with Agenus’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, critical needs of the role, and internal equity.
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Agenus is Delighted to Provide you With a Comprehensive Benefits Plan, Including Some of the Following:
Highly competitive and inclusive medical, dental and vision coverage options (US & UK) Flexible Spending Accounts for medical expenses and dependent care expenses (US) Flexible Vacation Plan (US & UK)-In a time when we move at the speed of light, what matters most is what we achieve, not how many hours we clock or accrue. We want people to take breaks when they need them most and own their time. Our philosophy at Agenus is that freedom to take this time will lead to clarity, creativity and innovation through rested and refreshed eyes. With our Flexible Vacation Plan, Agenus will not limit the amount of vacation you can take. It will allow you to take the vacation time as you need, while fulfilling your job responsibilities and making meaningful contributions to our mission. Memberships (US) Education Assistance Program (US & UK) 401k match (US) and Financial Planning tools, Private Pension (UK) Employee Stock Purchase Plans (US &UK) Employee Assistance Program (US &UK) Reward & Recognition Program (US & UK) Catered Lunch (site dependent) Onsite Yoga (UK) Free Parking (US & UK)
Our core values
The way we work sets Agenus apart.
We put the patient first.
We aspire to change the world, improving the experience and options available for every single cancer patient. The answers are out there, and patients are waiting.
We are bold, and we are one.
We believe that the only way to deliver on our goals is to aim high and work as one global team. We look for opportunities to challenge, collaborate with, and support one another. We aim to break conventional standards and perform at extraordinary levels.
We work with integrity, respect and honesty.
These three building blocks serve as pillars for how we behave, operate, and execute our mission.
We are a culture of ownership and accountability.
We hold ourselves accountable not only for exceptional results, but how we get our results.
We are obsessively curious and deeply committed to learning.
We live in a fast-paced environment that requires us to learn at or above the speed of change. We believe that curiosity fuels the desire to create, and learning provides the tools to progress.
We perform at our best every day.
Every day counts. We confront insurmountable obstacles, problems and choices with intellect, perseverance and hard work.
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