Merck Senior Specialist, Manufacturing & Lab Automation in Durham, North Carolina
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.
The Senior Specialist for Manufacturing & Lab Automation is responsible for providing technical support for automation for a GMP testing laboratory for sterile vaccine products. Responsible for resolution of severe automation problems, implementation of process control, data collection techniques, and troubleshooting in compliance with SLC, GMP, Data Integrity, safety, and environmental regulations. Actively support, participate and embrace an empowered team culture including significant interaction with manufacturing, quality and engineering groups. Supports a large spectrum of sophisticated automated systems within Laboratory Operations; providing multiple opportunities to learn new automation technologies and make a positive impact. Provides direct support to the laboratory operations team including leading cross functional teams and providing direct guidance to the Automation team.
Primary Activities include, but are not limited to:
Understands and supports all GMPs, safety, and environmental regulations.
Reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.
Leads investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions.
Evaluates automated and information technology systems, and develops strategies to optimize and ensure quality and stability of automation systems through future expansion, replacement, or upgrade.
Assists in the Automation Lead in the training, development, motivation, and assignments for employees within the Automation within the framework of company policies.
Coordinates projects with staff group for timely implementation.
Uses technical knowledge to assure the efficient operation of variety of automated processing and information technology systems. Leads in installing and placing new equipment into operations. Develops solutions for automation problems. Prepares automation cost information to support profit plan. Responsible for control of automation charges to budget.
Participates in audits and training programs in the area of responsibility.
Project coordination leadership and implementation of troubleshooting activities and change control.
Initiate and lead collaboration within the Operations, Quality and Technical organizations to resolve complex problems.
On-floor support of manufacturing activities.
Identify and implement process/equipment improvements and manufacturing efficiencies.
Serves as liaison with corporate and divisional automation and IT groups.
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: Allen Bradley PLC (or equivalent), Lean Manufacturing /Six Sigma methodology, contractor management.
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.
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Job Manufacturing Automation
Title: Senior Specialist, Manufacturing & Lab Automation
Primary Location: NA-US-NC-Durham-RTP
Requisition ID: MAN006628
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