Job DescriptionWe are seeking a highly motivated individual to partner with the Operations, Quality Operations, and Technical Operations to meet the targeted supply and compliance initiatives within the Durham manufacturing site. Specifically, you will be responsible for providing validation support in the production of current and new vaccines in the Global Vaccine and Sterile Manufacturing organization.The successful Specialist candidate will be energetic and technically sound, with strong interpersonal, communication, and collaboration skills responsible for supporting IQ and OQ while specifically providing cycle development and Process Qualification (PQ) for equipment and systems supporting The Maurice R. Hilleman Center for Vaccine Manufacturing.This role will contribute to the performance and results of a department, provide validation guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Off-shift and weekend coverage will be required at times based on business unit needs and specific assignments.Specific assignments may be focused in one area or span across multiple areas of focus.Additional Responsibilities
Provide validation support for qualification studies associated with the development and implementation of processes, systems, and facilities related to vaccine drug substance and key intermediates e.g. buffers, media and cleaning solutions.
Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.
Lead validation studies and author the associated documentation
Participate in the equipment specification, selection/procurement, and qualification phases of vaccine capital projects
Collaborate with internal/external partners, e.g. Other Company sites, Procurement, Raw Material & Component Suppliers
Execute development and Performance Qualifications in media preparation, vaccine filling, lyophilization, and capping/inspection unit operations, including engineering runs and process validation lots of vaccine products. Act as subject matter expert (SME) for issues pertaining to these programs.
Author, review, and/or edit validation documents to support regulatory filings
Support Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes.
Lead validation topics in regulatory inspections by presenting and defending validation documentation.
Develop technical and manufacturing documents necessary for development studies, cleaning, sanitization, depyrogenation and sterilization process validation.
Participate in the feasibility activities working alongside Operation's team members to develop reliable, consistent manufacturing processes that meet current Good Manufacturing Practices (cGMP) requirements.
Provide documented evidence that processes are consistent and reliable through challenges against pre-established criteria.
Provide technical support to help develop and execute project plans; and obtain and analyze relevant data and prepare appropriate reports for regulatory submissions.
Provide contributions to the planning, design, and implementation of segments of new facilities, systems and equipment in a cost effective and timely manner.
Design validation studies, author and approve protocols, and ensure alignment with corporate standards and site guidance for validation.
Author or update Validation SOPs
Assist in authoring the regulatory submissions for the facility and present your work to multiple regulatory agencies throughout the pre-approval inspection processes.
Assist with troubleshooting and effectively resolving problems. Develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent recurrence. The successful candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve it at root cause.
Maintain alignment with internal Technical personnel regarding validation practices for products, processes and equipment.
Partner with Operations, Quality, and Automation functional areas on validation study implementation.
Education Requirements
Bachelor of Science Degree in Engineering or Life Sciences
Required Experience and Skills
Pharmaceutical manufacturing within a current Good Manufacturing Practices (cGMP) environment
Minimum two (2) years of relevant experience
Authoring technical documentation within a current Good Manufacturing Practices (cGMP) context
Effective and positive written and verbal communication skills
Project strategic plan development and management
Demonstrated ability to work both independently and as a part of a Team
Preferred Experience and Skills
Bulk upstream and/or downstream vaccine processes within a current Good Manufacturing Practices (cGMP) environment
Facility, equipment, and process start-up in a sterile current Good Manufacturing Practices (GMP) environment
Sanitization and Sterilization validation (SIP, autoclaves, depyrogenation ovens, VHP)
Cleaning validation (CIP, COP)
Validation experience in support of Good Manufacturing Practices process demonstration (IQ/OQ/PQ)
Sustaining the validated state through change management and continuing validation studies
Strong technical problem-solving abilities
Familiarity with regulatory requirements
Responding to regulatory questions with multiple agencies (e.g. FDA, EMA)
In person presentation of technically complex subjects to regulatory inspectors
Work well under pressure and achieve results within tight deadlines
NOTICE 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. VETJOBS #EBRGEmployees 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 HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) 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 Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)We 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 Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.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:DomesticVISA Sponsorship:NoTravel Requirements:No Travel RequiredFlexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:05/15/2024A 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.Job Posting End Date: 05/15/2024A 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.Requisition ID: R293306