Validation Engineer (Junior Level)

Company: Actalent
Location: Cambridge
Posted on: March 16, 2023

Job Description:

Position: Validation Engineer II Location: Cambridge, MA Benefits: PTO, Paid Holidays, Onsite Parking, 10% Year End Bonus, Equity, Healthcare Benefits, 401k Plan, Tuition Assistance, Commuter Benefits, Fitness Reimbursement, Stock Program Department Description:The Validation department performs equipment, utility, cleaning, sterilization, software, and process validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for cell therapies products. The department also functions as the liaison with the Metrology department and performs all equipment ownership and quality assurance review responsibilities associated with site calibration activities.Position Summary:--- Responsible for performing validation projects in a GMP biotech manufacturing facility.--- Develop and publish new validation project plans and protocols, execute protocols and write final reports with little to no supervision.--- Participate in equipment failure investigations, corrective/preventive actions and equipment release. Provide final approval for equipment release.--- Provide technical assistance to less experienced technicians/specialists.--- Routine and effective communication with immediate supervisor and other personnel within the group in addition to outside the department.--- Review and approve validation and calibration documentation.Required Qualifications:--- Bachelor's Degree or equivalent --- 2-4+ years of experienced with process, equipment, utility, and/or software validation in a GMP regulated environment.Preferred Qualifications:--- Proficient with GE Kaye Validator and/or ValProbe data acquisition systems.--- Working knowledge of GMPs.--- Experience with Microsoft Office including Excel, PowerPoint, Word, Project, and Visio.--- Familiarity with temperature chamber, sterilization, cleaning, software and depyrogenation qualifications.--- Prior experience with troubleshooting, investigating and effectively documenting deviations and discrepancies on project execution.--- Experience with writing validation protocols, project plans and final reports and managing validation projects.--- Ability to read/interpret engineering drawings and design documents.--- Knowledge of risk management tools and techniques.--- Knowledge of international regulatory requirements. About Actalent: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions. The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Cambridge , Validation Engineer (Junior Level), Engineering , Cambridge, Massachusetts