Lead Tech, Operations Lyophilization Night Shift

Job Description

This is a Night shift position 12.5 hour (6:30 PM-6:30AM) rotation (2-2-3).

The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with expertise working in aseptic production and manufacturing Lead Technician is a manager developmental role and will serve on the Operations leadership responsibilities of the Lead Technician include direct support of operations on the production floor coordination across processing suites real-time batch record review execution of aseptic processing requirements as needed adherence to Good Manufacturing Practices and leading in a team environment to accomplish shift and departmental ideal candidate for this position has demonstrated the ability to manage their own work activities as well as activities of others contributing toward the success of the team through the use of their decision-making and problem-solving skills and their knowledge of aseptic manufacturing.

Responsibilities include but are not limited to:

• Maintains qualification in the specified suite in the posting (at minimum).
• Maintains gown qualification.
• Assists Manager with coordination of daily work schedules coordinates processing activities across suites and effectively communicates performance targets.
• Assists Manager in leading a team-based culture through continuous improvement activities
• Assist Manager with facilitating shift change.
• Manages training progress of suite operators and assigns daily roles to support efficient training.
• Observes critical processing steps and provides real-time feedback.
• Performs inventory control and cycle counts. Resolves and reports issues with product accountability and SAP system discrepancies.
• Executes real-time batch record review and ensures timely closure of shopfloor order.
• Reviews and completes documentation to support production activities including batch record events and management of forms and labels on the shop floor.
• Collaborates with stakeholders and customers to resolve production related issues
• Demonstrates a strong problem-solving ability to troubleshoot and communicate appropriately and effectively
• Conforms to established safety procedures in accordance with OSHA and other regulatory agencies
• Identifies and addresses compliance environmental safety and process deviations as required and escalates to appropriate personnel.
• Attends and actively participates in safety & quality walkthroughs 5S kaizen events or any other operations initiatives as required.
• Serves as a back-up to the Operations Coach on shift as required.
• Serves as back-up to the Lead Tech operational compliance role as required.

Education Minimum Requirement:

• High School Diploma or equivalent is required for this position.

Required Experience and Skills:

• Qualified in the suite specified to the posting.
• At least four (4) years GMP manufacturing/processing experience or at least two (2) years GMP manufacturing/processing experience with a Bachelors degree in Life Science or Engineering
• Must be willing to work 12-hour night shift (6:00PM-6:30AM) on a rotating 2-2-3 that this schedule does include working alternating weekends and holidays
• Must be able to successfully pass and maintain aseptic gowning 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.
• Must be willing to be qualified in aseptic operations and perform operator roles as needed.
• Must be willing and able to lift 50 lbs. bend stoop squat crawl twist climb ladders and wear a respirator
• Must be willing to be vaccinated/blood tested for titer for products manufactured within the facility if needed.
• Computer literacy (internet browsers e-mail spreadsheets word processing)
• Experience with batch record execution including good documentation practices

Preferred Experience and Skills:

• Bachelors degree in Life Science or Engineering
• Associates degree in Life Science or Engineering
• BioWorks Certificate (working in an FDA regulated industry)
• Environmental Monitoring and Sampling
• Proficiency in the use of SAP in a manufacturing setting
• Review of Electronic Batch Record
• Certified Yellow Belt/Green Belt MSJR #VetJobs #EBRGs

Required Skills:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

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