Senior Specialist, Engineering- Validation

Job Description 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 applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents O