Senior Specialist, Engineering- Validation

Primary Responsibilities Providing a leadership and technical supportive role in the areas of Steam Sterilization, Dry Heat Depyrogenation, Steam Decontamination, Vaporized Hydrogen Peroxide Decontamination, Controlled Temperature Unit Temperature Mapping and Warehouse Temperature Mapping Performance Qualification Validation activities (but not limited to); Scheduling and executing PQ Validation activities Scheduling and managing PQ protocol close-outs Performing technical investigations and analyses Driving to and recommending corrective actions and seeing them through to successful/sustainable implementation Reviewing procedural revisions to be compliant with regulatory expectations Data analysis and Second Person Review Troubleshooting activities associated with all aspects of PQ execution Final report and procedure writing and review Change control evaluation / implementation QMS evaluation / alignment SME presentation to regulatory inspectors Directly interfacing with Project / IPT customers to manage pinches / challenges Maintain team accomplishment metrics and present as needed Manage of team of Contractors and / or P1 and P2 employees (including but not limited too) Justifying appropriate team headcount Authoring job postings / conducting interviews / evaluating candidates as needed Assigning / Assisting with prioritization of work responsibilities Evaluating performance and providing regular feedback Sponsoring employee growth and developmental opportunities through routine 1:1 developmental coaching Participating in Year End assessment activities as applicable Sponsoring the team to achieve Safety and Quality compliance excellence Multiple opportunities will be provided to stream-line team performance and effectiveness Multiple opportunities will be provided to grow as both a SME and people manager Education Minimum Requirement: Bachelor or Master degree in, biology, biochemistry, biochemical engineering, biological systems engineering, biomedical engineering, chemical engineering, computer science, integrated science or related life science or engineering discipline Required Experience and Skills Minimum five (5) years of pharmaceutical manufacturing industry Working in a cGMP environment Effective problem-solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications Willingness to work as a contributing member of a dynamic team of individuals Experience acting as a team leader Knowledge and/or experience in: CTU/WH qualification / validation; Dry Heat Depyrogenation qualification / validation; Steam Sterilization / Sanitization qualification / validation; VHP Decontamination qualification / validation Required Skills: Biochemistry, Biopharmaceutical Industry, Good Manufacturing Practices (GMP), Pharmaceutical Manufacturing, Steam Sterilization, Sterilization, Sterilization Validation, Temperature Mapping, Validation Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other