Job Description Our Manufacturing Division, 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.
At our manufacturing campus in Elkton, Virginia, we currently have a Senior Validation Specialist, Engineering position. The manufacturing facility is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains "" just a short distance from the University of Virginia and James Madison University.
The successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of pharmaceutical/biopharmaceutical/vaccine product manufacturing facilities.
Assignments and duties will include:
Achieving Safety, Quality, and Environmental compliance excellence in all assignments
Learning new processes and procedures
Developing and managing the facilities by:
Coordinating with network validation SMEs and sister sites to ensure adherence to GMP requirements and alignment to overall program strategies
Providing an overall technical supportive role in the areas of Cleaning and Process Validation
Authoring and reviewing CIP / CPV / VMP documents
Performing technical investigations and statistical analyses
Recommending corrective actions and seeing them through to successful / sustainable implementation
Maintaining metric trackers
Providing oversight / coaching / mentoring / training to other engineers
Writing / reviewing / improving documentation to ensure technical and regulatory compliance
Representing the company during internal and regulatory inspections.
Contributing to data, compliance and safety reviews
Working as a contributing member of a dynamic team of highly trained professionals
Education Minimum Requirement:
B.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and minimum of 4 years of relevant industry experience
M.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of 3 years of relevant industrial experience
Required Experience and Skills:
Experience working in a regulated environment
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.
Highly proficient organizational skills which contribute to the ability to efficiently multi-task several objectives at the same time
Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills
The 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 willingness to work as a contributing member of a dynamic team of individuals.
Preferred Experience and Skills:
Experience with SIP, Decontamination, VHP, Clean Out of Place, CTU and Sterilization Validation
Biologics or vaccine manufacturing experience
Experience in Quality Operations and Technical Operations
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
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, 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.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.