Reagent Bulk & Fill Technical Specialist - Variable Shift

• Perform manufacturing and assembly tasks for both clinical and commercial products.
• Accurately weigh, measure, and verify raw materials and manufacturing components to ensure proper batch composition.
• Participate in bulking, filling, aliquoting, cleaning and packaging of bulk materials into final product formats.
• Assigned to multiple functional areas within Manufacturing to support operational flexibility and cross-training.

Responsibilities

• Serve as Backup Team Lead and Supervisor by leading Tier meetings, ensuring team utilization is optimized and documentation forms are completed.
• Responsible for submitting Device History Records (DHR) to Quality Assurance (QA).
• Communicate with Warehouse and Planners to manage schedule updates or changes.
• Document and report key performance indicators (KPIs) at the end of each shift to support operational transparency and performance tracking.
• Lead troubleshooting efforts within the filling process and escalate issues to the appropriate departments to ensure timely resolution.
• Independently perform and oversee the setup and operation of reagent filling equipment, including automated fill machines.
• Lead and compile all improvements across the manufacturing lines, aligning with MTS to ensure that critical and high-risk initiatives are executed on time.
• Serve as the technical lead across all areas of bulk and fill operations.
• Collaborate with Manufacturing Sciences to support product transfers and lead or assist in technical investigation.
• Oversee the revision, editing, and formatting of controlled documents, including Device Master Records and Standard Operating Procedures (SOPs), ensuring clarity, compliance, and consistency.
• Distribute and review count sheets, verify inventory accuracy, identify discrepancies, and lead investigations to resolve them.
• Coordinate and conduct laboratory walkthroughs to ensure readiness for audits, verifying compliance, documentation accuracy, and operational standards.
• Leading the handling of finished goods for use in blood screening kits.
• Perform in-process visual inspection of finished goods for use in blood screening kits as they come off the fill line.
• Perform sample gathering of semi-finished goods for use in blood screening kits for QC and Bio-burden.
• Oversee material handling tasks, including folding product boxes and trays, and staging materials for process orders.
• Receive and verify the accuracy of materials transferred from the warehouse to ensure readiness and compliance.
• Understand and execute written procedures in accordance with current Good Manufacturing Practices (cGMP), and ensure team adherence through guidance, oversight, and support.
• Maintains detailed and accurate device history records with cGMP and forwards them in a timely manner for review.
• Maintains accurate and complete training records.
• Maintains and archives Manufacturing log sheet records.
• Demonstrates proficiency in managing training documentation and GTP records, with a focus on accuracy, clarity, and timely updates.
• Performs notebook, development, pilots, validation and commercial builds per GMP guidelines for reagents/sub-assemblies builds.
• Promptly escalate product-related concerns, safety incidents, or personal issues that may impact production timelines to management.
• Consistently follow all established safety protocols and procedures.
• Demonstrate advanced proficiency in SAP transactions to verify material availability, consumption, labor hours, sampling data, and accurate material labeling, ensuring traceability and compliance with operational standards.
• Facilitate team and cross-functional discussions to gather input, align on corrective and preventive actions, and drive continuous improvement.
• Provides support to Manufacturing senior staff.
• Participates in cost savings and process improvement activities and support with Change controls tasks and activities.
• Work in cross-functional teams to lead process improvement projects within the manufacturing department.
• Act as a mentor and provide training to Reagent Bulk & Fill Technicians across all levels (I–IV), supporting their development and ensuring consistent performance standards.
• Participate in cross-functional communication to ensure alignment across departments.
• Adhere to target manufacturing timelines and support schedule execution.
• May cross-train in other manufacturing and operational areas based on business needs.
• Serve as a specialist in Device History Record (DHR) review, ensuring documentation accuracy and compliance.

Knowledge, Skills, and Abilities

• Demonstrated technical expertise specific to the role and manufacturing environment.
• Advanced knowledge of laboratory safety protocols and accurate record-keeping practices.
• Proficient in GDP, GMP, ISO regulations, and Bloodborne Pathogen safety training.
• Skilled in Microsoft Office applications for documentation, reporting, and communication.
• Strong attention to detail, organizational skills, and a collaborative, team-oriented mindset.
• Capable of following both oral and written instructions with precision.
• Advanced understanding of laboratory science, including procedures, techniques, instrumentation, and equipment.
• Effective communicator across cross-functional teams, ensuring alignment and operational efficiency.
• Proven ability to collaborate with members of other departments to support shared goals.

Education

Requires High School Diploma, GED. Associates Degree in Biology, Mechanics, Engineering or related field is preferred.

Experience

• At least 8 years of experience as a reagent fill or bulk formulation technician or equivalent in a regulated setting.
• At least 5 years of experience troubleshooting fill/bulk equipment as a Reagent Fill Technician, Bulk Technician, or equivalent role in a regulated setting.
• At least 4 years of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required.
• Mechanics certification desired.

Occupational Demands

The physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Visually inspect components and final kits for compliance and specifications. Close vision (20 inches or less) will be utilized and some color identification will be required. Frequently required to stand, sit, use hands/fingers to handle or feel, perform reaching, bending, stooping or kneeling motions. Operators may be required to walk for a considerable amount of time. May occasionally lift, carry, push, pull or otherwise manipulate objects up to 40 pounds in weight. Will be required to frequently or continuously lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight. May move heavier (greater than 50 pounds) objects and/or materials using carts or pallet jacks. The applicant must be flexible and willing to work first, second, and third shifts, including weekends, based on production schedule needs. The applicant must be flexible in adjusting PTO according to shutdown schedules and production needs.