Job Description

Job Description:

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, manufacturing plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.

We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of sterile products, making accessible our company's next generation of Vaccines and Biologics. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We have an exciting opportunity for a Specialist to join the technical operations team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This new facility will include end-to-end processing of both drug substance and drug product, including product inspection, and quality control laboratories.

The Specialist, Technical Operations will be responsible for providing technical support as part of one of the drug substance or drug product Technical Operations teams.

Position Responsibilities:

• Reporting to the Technical Operations Associate Director the incumbent will independently manage project assignments and will escalate potential delays and develop remediation plans when possible.

• Design, author and execute protocols in support of the technical transfer using the Technical Operations laboratory facilities and/or full-scale production equipment.

• Provides technical support for complex technical problems impacting manufacturing and other investigations including processes and equipment.

• Authors and updates technical and manufacturing documents necessary for change controls, batch records, standard operating procedures, corrective and preventative actions among others.

• Provides on-the-floor support of operational and technical (process/equipment) issues on the shop floor.

• Support quality risk assessments and regulatory inspections.

• Supports team safety, environmental, and compliance objectives.

• Collaborates effectively with the area manufacturing Coaches, Operators and support groups such as Quality and Planning.

Required Experience and Skills:

• Bachelor of Science (BS) degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline

• Minimum of 2 years' experience in pharmaceutical operations, technical services, and/or quality operations

• Aseptic cGMP manufacturing experience, in biological drug substance or drug product.

• Experience with aseptic process simulations (APS), electronic batch records, and/or change controls.

• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

• Effective decision making, problem solving and communication skills. Ability to manage multiple priorities.

• Demonstrates interpersonal, technical aptitude and problem-solving skills

• Communication, leadershipand teamwork skills.

Preferred Experience and Skills:

• Experience with facility, equipment, and process start-up in a sterile GMP environment.

• Capital project experience.

• Experience using Lean/Six Sigma tools.

#EBRG VetJobs

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, 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:

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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:R321927