Senior Specialist, Purification - Technical Operations
- Charlottesville, VA
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 Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. 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 the campus in Elkton, Virginia, we currently have opening for a Senior Specialist 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 pharmaceutical, biopharmaceutical, or vaccine product manufacturing facilities.
This role specifically supports a vaccine Purification group. We are seeking an individual to partner with Manufacturing and Quality groups in the Purification area to provide exceptional technical support, play a key role in implementing projects, improve the processes, and meet and surpass metrics/objectives of the area.
If you are the kind of individual who thrives on challenge and possess the technical, leadership and business, and communication skills that are of value to our business, we invite you to apply. Consistently cited as a great place to work, we discover, develop, manufacture and market a wide range of vaccines and medicines to address unmet medical needs. Each of our employees is joined by an extraordinary sense of purpose - bringing our Company's finest achievements to people around the world.
- Lead a team of engineers with the objective of planning and implementing projects in support of maintaining and improving the quality, reliability, and efficiency of the Purification manufacturing process. Provide technical guidance for said small and capital projects from concept through implementation.
- Manages activities associated with the projects. Examples (but not limited to) include managing documentation updates (e.g. SOPs, batch sheets, recipes), training, quality risk assessments, change control management / filing support, and validation activities such as equipment qualification, process validation, and cleaning validation/monitoring activities.
- Lead and support continuous process improvement activities to enhance process performance.
- Provides technical expertise related to the process, equipment, and manufacturing and cleaning processes in response to deviations to identify point of occurrence, root cause, and corrective / preventative actions. Demonstrates ability to lead and resolve complex technical issues and investigations.
- Writing, reviewing, improving documentation for technical and regulatory compliance excellence
- Provides technical expertise for compliance activities such as audit and regulatory support.
- Supports routine supply manufacture by providing on going technical support to operations, maintenance, and quality organizations.
- Provides personal career development for employees through ongoing coaching, Employee Development Plan (EDP), and career mapping.
- Achieving Safety, Quality, and Environmental compliance excellence in all assignments
- Learning new processes and procedures
Position Qualifications :
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 a minimum of six years of relevant industrial 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 four years of relevant industrial experience
- Ph.D. in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and relevant industrial experience
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.
Preferred Experience and Skills:
- Working in a c urrent Good Manufacturing Practice (cGMP) environment
- Biologics or vaccine processing
- Sterile processing
- Project Management
- Leadership roles
- Participation in regulatory agency inspections
Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are ...
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
US and Puerto Rico Residents Only:
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We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
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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.
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