The Senior Specialist for Lab Automation is responsible for providing automation system technical support for the building and expansion of a GMP testing laboratory and a process support laboratory for sterile vaccine products. Responsible for the validation and administration of COTS Laboratory Systems, support of Technology Enabled Laboratory (TEL) efforts, data collection techniques, and troubleshooting in compliance with System Life Cycle (SLC), GMP, Data Integrity, safety, and environmental regulations. Actively support, participate and embrace an empowered team culture including significant interaction with Laboratory Operations, Quality, IT and Engineering groups. Provides direct support to the Laboratory Operations teams, including leading cross functional teams and providing direct guidance to the Lab Automation team.
Primary Activities include, but are not limited to:
Understands and supports all GMPs, safety, and environmental regulations,
Coordinates with staff and contractors to guarantee timely qualification of all new and updated systems,
Authors and/or reviews automation documents, preventive maintenance procedures, and SOPs to ensure compliance with GMPs and safety.
Evaluates automated and information technology systems to ensure quality and stability,
Support IT and TEL team members to ensure all infrastructure and networks requirements are met in the building expansion; complete change controls for TEL initiatives as necessary,
Participates in audits and training programs in the area of responsibility,
Leads troubleshooting and investigations of automation incidents to prevent recurrence, including the development and implementation of corrective actions and change controls, and
Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems.
Education Minimum Requirement:
Bachelor’s Degree in science, engineering, or mathematics
Required Experience and Skills**:
Minimum 5 yrs. of experience in laboratory automation or equivalent.
Minimum of 3 yrs. of GMP computer systems validation experience. Computerized laboratory instrument and computer validation and systems lifecycle development methodology experience required.
Preferred Experience and Skills:
Experience in the following areas is desired: Structured Problem Solving, Lean Manufacturing /Six Sigma methodology and contractor management.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
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.
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.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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No Travel Required
Flexible Work Arrangements:
1st - Day
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