Lead Technician Job-Merck

Location: Durham, North Carolina, USA

    

Company: Merck

Job Position: Lead Technician

JOB DESCRIPTION:

Qualification:

Education & Experience

1. Bachelor’s degree in Life Science or Engineering

2. Associate’s degree in Life Science or Engineering
3. BioWorks Certificate (working in an FDA regulated industry)
4. Environmental Monitoring and Sampling
5. Proficiency in the use of SAP in a manufacturing setting
6. At least four (4) years GMP manufacturing/processing experience or at least two (2) years GMP manufacturing/processing experience with a Bachelor’s degree in Life Science or Engineering
7. Must be willing to work 12-hour day shift (6:00 AM to 6:30 PM) on a rotating 2-2-3 schedule.  Note that this schedule does include working alternating weekends and holidays
8. Must be able to successfully pass and maintain aseptic gowning qualification.  Aseptic gowning requires that all skin and hair be covered through wearing the following: beard/mustache cover, hair net, hood and face mask, goggles, jumpsuit, gloves and boots.
9. Must be willing to willing to be qualified in aseptic operations and perform operator roles as needed.
10. Must be willing and able to lift 50 lbs., bend, stoop, squat, crawl, twist, climb ladders, and wear a respirator
11. Must be willing to be vaccinated/blood tested for titer for products manufactured within the facility if needed.
12. Computer literacy (internet browsers, e-mail, spreadsheets, word processing)
13. Experience with batch record execution, including good documentation practices.

Job Responsibility:

1. Assists Manager with coordination of daily work schedules, coordinates processing activities across suites, and effectively communicates performance targets.

2. Assists Manager in leading a team-based culture through continuous improvement activities
3. Assist Manager with facilitating shift change.
4. Observes critical processing steps and provides real-time feedback.
5. Completes environmental monitoring schedules for shift.
6. Performs inventory control and cycle counts. Resolves and reports issues with product accountability and SAP system discrepancies.
7. Executes real-time batch record review and is responsible for alarm monitoring and reconciliation
8. Reviews and completes documentation to support production activities, including batch record events and management of forms and labels on the shop floor.
9. Collaborates with stakeholders and customers to resolve production related issues
10. Demonstrates a strong problem-solving ability to troubleshoot and communicate appropriately and effectively
11. Conforms to established safety procedures in accordance with OSHA and other regulatory agencies
12. Identifies and addresses compliance, environmental, safety, and process deviations as required and escalates to appropriate personnel.
13. Attends and actively participates in safety & quality walkthroughs, 5S, kaizen events, or any other operations initiatives as required.
14. Serves as a back-up to the Operations Specialist on shift, as required.