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Job Description

This role is a Senior Specialist who would focus on Drug Substance Localization as well as Drug Product Localization. The function of this position is to provide engineering technical support for the manufacture of Drug Substance and Drug Product at external partners as well as at the company's West Point, PA location. The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area such as localization or span across multiple areas of focus based on the West Point Technical Operations business needs and priorities.

The selected candidate will be responsible for:

• Serving as the main point of contact and SME for a product franchise support of drug substance (Fermentation and Purification) and/or drug product at external partners. May require support of additional products or family of products. The support can include but is not limited to tech transfer, validation, change controls, regulatory submissions, deviations and training of employees from external partners.

• Responsible for responding to questions from external partners.

• Collaborate effectively with the external partners and the company's External Manufacturing.

• With in depth product expertise, complete deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.

• Authoring technical protocols, executing studies and reporting results/conclusions in support of product tech transfers, process improvement projects and deviation investigations. The individual will be required to utilize sound engineering principles to support qualified validation processes as required per current Good Manufacturing Practices (cGMPs).

• Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation or process troubleshooting or to provide immediate responses to deviations and/or protocol exceptions.

• Supporting team safety, environmental, and compliance objectives.

• Collaborating effectively with the area Managers, Operators/Mechanics, support groups (Mechanical Services, Automation, Technical Operations), Quality, and Planning.

Other responsibilities that the candidate will get involved in as required:

• Supporting product Annual Review expectations including Continued Process Verification Reports, including pulling data, generating charts and statistically analyzing the data to identify whether preventative actions are required.

• Approving new or updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures).

• Performing validation assessments for proposed changes impacting the qualified processes.

• Managing investigation, project and validation study timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.

• Actively using and championing the use of Lean Six Sigma (LSS) tools, both problem solving and day-to-day operational activities

• Leading cross functional teams and acting as an individual contributor to drive change control and improvement projects across compliance, and strategic, including projects aimed at improving Right-First-Time performance, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.

• Authoring and approving Change Control documentation for complex process, validation, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines.

• Preparing source documentation for regulatory filings, supporting and serving as a lead SME during regulatory inspections related to process overviews, investigations, projects and validation.

Education Minimum Requirement:

• B.S. or equivalent in Science Related Field

Required Experience and Skills:

• Engineering or Science educational background

• Minimum of 5-years of post BS degree experience in vaccines in support of Production, Process Engineering, Technical Operations or related experience

• Hands-on experience in supporting fermentation or purification of vaccines

• Hands-on experience in supporting formulation and aseptic filling including manufacturing scale filling isolators, RABS, or closed system processing

• Product franchise Tech Services experience

• Support of deviation investigations

• Support project work

• Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills

Preferred Experience and Skills:

• Experience with Trackwise, MEDS, SAP, MII, Delta V

• Experience with change control documentation and execution

• Participation in internal audits, regulatory inspections and/or interactions with regulatory agencies.

• Experience with Clean-in-Place and Sterilize-in-Place systems

• Ability to read Piping and Instrumentation Diagrams is desired

• LSS experience

• Experience with Tech services support activities for introduction or launch of new product

Travel requirement of 25%

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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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 (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/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.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 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:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

05/20/2024

*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: 05/20/2024

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: R292464