Specialist, BioSterile Validation

Durham, NC, US
April 16 2018
Organization Type
Requisition ID: CHE005895

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.


As part of the Merck Manufacturing Division (MMD), Durham BioSterile Validation is seeking a highly motivated individual to partner with the Operations, Quality Operations, Technical Operations and the Focus Factory 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.



In this role you will:


Lead, execute, and document validation activities for initial validation and continuing validation.

Collect and interpret information to conceive, develop, and implement solutions to a range of projects and support activities.

Maintain alignment with internal technical personnel regarding validation practices for equipment, processes and products.

Partner with Operations, Quality, and Technology functional areas on validation study implementation which may require off-shift and weekend execution.

Investigate and resolve validation test failures and/or atypical events which require an application of a variety of investigation techniques and analysis, and cross-functional partnering to draw sound scientific conclusions with respect to validation compliance and/or product quality impact.

Maintain cGMP compliance posture with respect to validation and manufacturing activities.

Execute development and Performance Qualification in media preparation, bulk manufacturing, vaccine filling, lyophilization, and capping/inspection unit operations, including engineering runs and process validation lots of vaccine products.

Provide leadership for troubleshooting and efficiently resolving manufacturing problems. Effectively develop and implements corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply of vaccine products.

Prepare and/or provide review and guidance for regulatory filings, process descriptions, atypical process reports, and change requests.

Support all quality and safety initiatives.

Foster empowered teams to achieve site mission, vision and goals through efficient and safe operation of process systems, compliance with current Good Manufacturing Practices resulting in product that is safe and efficacious.


Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.


Position Qualifications:


Education Minimum Requirement:


B.S. in Engineering or Science


Required Experience and Skills:


A minimum of 2 years direct validation experience (B.S. degree) in biological, pharmaceutical, or chemical manufacturing support roles.


Preferred Experience and Skills:

Demonstrated ability to work both independently and as a part of a team

Experience leading small groups in a GMP environment

Familiarity with regulatory requirements

Strong technical problem-solving abilities

Demonstrated effective written and verbal communication skills; ability to influence both peers and management in building consensus

Strong collaboration and leadership skills

Sterilization validation (SIP, autoclaves, depyrogenation, VHP, gamma)

Cleaning validation (CIP, COP, manual)

Controlled Temperature Unit validation (warehouses, incubators, freezers, refrigeration units)

Other validation experience in support of process demonstration (IQ/OQ/PQ, shipping, transportation, container closure, sterile filtration, PPQ)

Sustaining the validated state through change management and continuing validation studies


Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.

If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to staffingaadar@merck.com.


Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:


EEOC Poster

EEOC GINA Supplement


Job: Chemical Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 2
Shift (if applicable): 1st
Hazardous Materials: Yes
Company Trade Name: Merck