Senior Operations Specialist - Facilities and Project Lead

Job DescriptionThe 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 fa cility-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!#MSJRNOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.VETJOBSEmployees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERECurrent Contingent Workers apply HEREUS 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.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 ActsU.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not ApplicableShift:1st - DayValid Driving License:YesHazardous Material(s):N/AJob Posting End Date:08/10/2024• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.