Validation Specialist

Job Description We are seeking a Growth and Improvement minded Validation Specialist that can help drive our Strategic Operating Priorities.

• Invent - Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
  
• Execute - Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
  
• Adapt - Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
  
• Diverse Talent - We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
  
• Values and Standards - Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for Us
  

Summary, Focus and Purpose The Validation Specialist will be an energetic, technical contributor and leader with strong interpersonal, communication, and collaboration skills responsible for providing cycle development and PQ for equipment and systems supporting bulk biological processes (i.e. Sterile Supply, Adjuvant Manufacturing, Fermentation, and Purification). This position will primarily support vaccine drug substance site readiness via Validation program implementation, partnering with cross-functional teams (i.e. Maintenance, Global Engineering, Quality, and Operations} to ensure a successful technology transfer, filing, and licensure for a new HPV vaccine drug substance manufacturing facility. Additionally, 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. Key Functions

• Work independently and as a Team member with Integrity - Precision - Accomplishment - Motivational Ambition - Respect - Inclusion
  
• Primary support of Purification suite and Validation activities related to the vaccine drug substance
  
• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process
  
• Lead technical studies and author documentation associated with equipment, cleaning, and sanitization/sterilization activities.
  
• Support technical studies including engineering runs, stability and process validation activities by maintaining systems in a validated state.
  
• Provide SME knowledge for manufacturing, utilities and facilities investigations by authoring QNs, support product impact assessments, root cause analysis, and identifying corrective and preventative actions
  
• Perform impact assessments for validation, equipment, facility/utility and/or automation changes.
  
• Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments
  
• Support aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls
  
• Helps to establish empowered teams to achieve site mission, vision and goals through efficient and safe operation of process systems
  
• Compliance with current Good Manufacturing Practices and production of product that is safe and efficacious
  

Shift

• Monday through Friday; Day hours
  
• Off-shift and weekend coverage will be required based on business unit needs and specific assignments
  

Education

• Bachelor of Science degree in Engineering or Sciences with two years relevant experience or Master of Science Degree with relevant academic experience
  

Required Experience - Skills - Knowledge

• Experience in vaccine or biologics manufacturing within a cGMP environment
  
• Principled verbal and written communications
  
• Experience authoring technical documentation within a cGMP context (protocols/reports, investigations, and/or change controls)
  
• Proven leader with influence and outstanding problem solving skills
  
• Sustaining the validated state through change management and continuing validation studies
  
• Experience with validation documentation and execution
  
• Ability to read Piping and Instrumentation Diagrams
  
• Participate in the feasibility activities working alongside Operation's team members to develop reliable, consistent manufacturing processes that meet 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 submission 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.
  

Preferred Experience - Skills - Knowledge

• Experience with on-the-floor cGMP manufacturing support
  
• Authored complex process change control or deviation investigations
  
• Experience with in person presentation of technically complex subjects to regulatory inspectors
  
• Experience with technology transfer or startup methodologies for introduction/launch of a cGMP drug substance
  
• Experience with electronic systems:- SAP, ProCal, DeltaV and Kneat
  
• Experience with Kaye AVS and Valprobe datalogging systems
  
• Experience with Sanitization & Sterilization validation (SIP, autoclaves, depyrogenation ovens) and Cleaning validation (CIP, COP)
  
• Experience with performance qualification of sealers, welders, filter integrity testers, and CTUs.
  

Travel

• Up to 5 %
  

NOTICE FOR INTERNAL APPLICANTS In 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. Residents of Colorado Click here to request this role's pay range.- Employees 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 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. 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 EEOC GINA Supplement• Pay Transparency Nondiscrimination 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 U.S. Hybrid Work Model Effective 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 Carefully-
Merck & 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:
Regular Relocation:
No relocation VISA Sponsorship:
No Travel Requirements:
10% Flexible Work Arrangements:
Not Applicable Shift:
1st - Day, Not Indicated Valid Driving License:
No Hazardous Material(s):
N/A Job Posting End Date:
06/1/2024
*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. Job Posting End Date: 06/01/2024 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. Requisition ID: R296804