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.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

At our Company campus in Elkton, Virginia, we currently have openings for Senior Specialist Process Microbiologist position available on our Technical Operations team. The manufacturing facility is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains a short distance from the University of Virginia and James Madison University. A successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of biologic, vaccine, and sterile product manufacturing facilities.

Responsibilities include:

• Achieving Safety, Quality, and Environmental compliance excellence in all assignments

• Managing multiple technical and capital projects and assembling and leading multidisciplinary teams across many functional areas

• Learning new processes and procedures

• Leading and conducting technical investigations and analyses, recommending corrective actions, and seeing them through to successful, sustainable implementation

• Writing, reviewing, improving documentation for technical and regulatory compliance excellence

• Teaching, coaching, mentoring, and learning from team members

• Provide ongoing coaching and support to the IPT team members, to share their aseptic technical knowledge and promote best practices.

• Education and communication of personnel in Aseptic techniques, GMP requirements and regulations

• Microbiology Representative on Technical Agenda Teams and investigations

• Collaborates in the development and execution of the Facility-based Environmental Monitoring programs to include QRA execution.

• Process microbiology representative for Facility and Equipment Qualification Requirements

• Provides aseptic guidance on facility and process-related controls and changes.

• Has a good working knowledge of Analytical Microbiology Requirements and Systems

• Handling of non-conforming EM results and trend analysis

• Troubleshooting of suspected Microbiological Contamination incidents

• Participation in internal and external audits

• Responsible for the preparation, review and approval of relevant technical documentation, risk assessments, CAPA's etc.

• Participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

• Execution of Sterility and Environmental Quality Risk Assessments

Education Minimum Requirement:

• B.S. or B.A. degree in Biology,Microbiology or equivalent

• Minimum of five (5) years in manufacturing environment that includes quality assurance, quality operations, or engineering.

Required Experience and Skills:

• Strong problem solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field.

• Project management skills and experience

• Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.

• Ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.

• Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications.

• A strong desire to succeed and to help others to do the same.

• Working knowledge of regulatory expectations of Aseptic processing.

• Ability to interact directly with regulatory agencies

• Proficiency in the use of Microsoft Office Suite.

Preferred Experience and Skills:

• Working in a cGMP environment

• Biologics or vaccine processing

• Sterile processing

• Leadership roles

• Participation in regulatory agency inspections

• Master Degree in Biology,Microbiology or equivalent

• Ten (10) years in manufacturing environment that includes quality assurance, quality operations, or engineering.

• Ability to multi-task and manage/prioritize multiple projects and deadlines

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:

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:R339257