Job Description

Job Description:

• Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Specialist - Technical Operations Analytical Support

• The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state-of-the-art facility, established in 2004, manufactures our Company's lifesaving vaccines. Durham's Shopfloor Analytical Technical Specialist will be an energetic, technical leader with strong interpersonal, communication, and collaboration skills responsible for supporting implementation of analytical transfer process knowledge, post approval support, and post commercial assay enhancement activities for pipeline vaccine programs.

Responsibilities may include but are not limited to;

• Provide technical/team support for commercial analytical assays (UPLC, Solo VPE)

• Author technical documentation associated with the development and implementation of assays for product release, quality lab qualifications and method verification efforts

• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the analytical testing of vaccine products

• Participate in the equipment specification, selection/procurement, and qualification phases of new equipment

• Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments

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

• Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls

• Provide post approval support and subject matter expertise support to ongoing quality laboratory release activities.

• Support management and submission of samples to support commercial manufacture

Education Minimum Requirement:

• Bachelor of Science Degree in Biochemistry, Biology, Chemistry, Bioengineering, or related life science field.

Required Experience and Skills:

• A minimum of three (3) years experience with analytical testing in a laboratory or manufacturing environment

• Experience authoring technical documentation

• Experience in a cGMP environment

• Outstanding communication (written & presentation) skills

• Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development

• Experience supporting commercial analytical assays (UPLC, Solo VPE)

Preferred Experience and Skills:

• Experience with drug substance and drug product release, stability and extended characterization testing for vaccines and biologics

• Knowledge of data analysis

• Experience in commissioning, qualification, and project management of laboratory or pharmaceutical facilities.

• Experience with analytical method transfer.

Travel: <10% of the time

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

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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, Monday - 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".

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R328044