Senior Operations Specialist

4 weeks ago


Rahway, United States MSD Malaysia Full time

Senior Operations Specialist - Facilities and Project Lead Job Description The West Point, PA campus is our Company’s largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and/or final dosage forms for all our Company vaccine products and is growing to meet the vaccine demands of the future. The Building 50 Live Virus Vaccine Filling Facility Project team is seeking a highly motivated and experienced Senior Operations Specialist to join our team as a facilities and new vaccine filling & lyophilization facility at the West Point site. As a Senior Operations Specialist, you will be responsible for partnering with multiple functions to execute facility management, commissioning and qualification, startup, and operational readiness activities. This role reports into the Operations Associate Director and requires strong leadership and project management skills. Responsibilities: Manage Facility Transition, Operations, and Compliance: Oversee the transition of the facility from commissioning and qualification to operational status, ensuring compliance with safety, environmental practices, cGMPs, and SOPs. Collaborate with cross-functional teams to ensure seamless facility operations and maintain compliance with regulatory requirements. Provide Facility Support: Act as a point of contact for facility-related issues and provide support to various departments. Identify and address facility-related challenges to ensure smooth operations and minimize disruptions. Direct the facility SOP Program: Develop and implement a comprehensive Standard Operating Procedures (SOP) program for the new manufacturing facility. Ensure all SOPs are up to date, accurate, and compliant with regulations. Collaborate with subject matter experts to author and review SOPs as needed. Manage Change Control: Lead change control activities related to facility operations, ensuring proper documentation, evaluation, and implementation of changes. Collaborate with cross-functional teams to assess the impact of changes on facility operations and implement necessary modifications. Lead Projects in Support of Facility Startup and Improvement: Take ownership of projects aimed at improving facility operations, efficiency, and productivity. Coordinate with stakeholders to define project objectives, develop project plans, allocate resources, track progress, and ensure timely completion. Assure Compliance: Regularly audit facility operations to ensure compliance with safety regulations, environmental practices, cGMPs, and SOPs. Identify areas of improvement and implement corrective actions as required. Requirements: At least 5 years of relevant experience in a pharmaceutical, biotechnology, manufacturing or related industry. Strong understanding of facility design, commissioning and qualification, startup, and operational readiness processes. Proficient in developing and implementing Standard Operating Procedures (SOPs) for manufacturing facilities. Proven project management skills, including the ability to lead and prioritize multiple projects simultaneously. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Detail-oriented mindset with strong analytical and problem-solving abilities. Knowledge of regulatory requirements and compliance standards in the pharmaceutical industry. Familiarity with cGMPs and FDA regulations. Bachelor's degree in engineering, life sciences, or a related field or High School Degree with relevant work history. Preferred Skills/Background: Experience in facility start-up, including equipment and process qualification/validation. Facility Management experience in a manufacturing/cGMP environment. Familiarity with Lean Six Sigma or other continuous improvement methodologies. Knowledge of environmental health and safety practices. Previous experience in a startup environment or supporting the launch of a new manufacturing facility. Join our team and contribute to the success of our Drug Product Manufacturing Facility Startup. If you are a collaborative, detail-oriented professional with a passion for facilities management and project execution, we want to hear from you #J-18808-Ljbffr



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