Manufacturing Technician II

2 days ago

Toledo, Toledo, United States BioSpace, Inc. Full time
Job Summary

We are seeking a skilled Manufacturing Technician II to join our team at BioSpace, Inc. This is a direct labor position responsible for performing a variety of manufacturing tasks, including operating equipment, performing in-process monitoring, and supporting improvement activities to achieve high-quality products.

Key Responsibilities
  • Operate assigned machinery, including equipment set-up, recipe selection, and data entry on the manufacturing computerized system.
  • Perform manual packaging tasks, including hand packaging and rework of in-process and finished material.
  • Conduct visual quality inspection and sampling of in-process materials, escalating concerns to the Lead and Process Facilitator as needed.
  • Perform minor troubleshooting, including clearing minor jams and identifying equipment defects, and work collaboratively with technical resources to resolve equipment issues.
  • Perform inventory control and reconciliation activities, including the use of SAP and WES.
  • Perform cleaning, housekeeping, and line clearance activities to maintain a cGMP environment.
  • Perform batch record and GMP documentation entries, including mathematical computations as needed.
  • Be familiar with job-related safety procedures and hazards, including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls.
  • Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs, and established safety and quality procedures.
Additional Responsibilities
  • Support lean activities and process improvement work, including performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis.
  • Act as a certified OJT trainer on the team, training and conducting evaluations on other team members for training qualifications.
  • Review process documents, including operational SOPs, forms, and batch records for accuracy, and identify and provide suggestions for process improvement while maintaining quality and cGMP compliance.
  • Execute protocols as required for equipment qualification and process validation work.
  • Be flexible and support other work areas within the department as needed.
Requirements
  • Experience in a pharmaceutical or cGMP regulated environment.
  • Able to effectively understand, read, write, communicate, and follow instructions in the English language.
  • Good attention to detail, capable of keeping accurate records, and performing mathematical calculations.
  • Able to acquire and maintain all required certifications and qualifications for the assigned work area.
  • Capable and motivated to learn new skills and develop new capabilities on an ongoing basis to contribute to the success of the department.
  • Ability to work effectively in a team environment.
  • Candidate should possess the ability to work in and adapt to a changing/demanding environment.
  • Some overtime may be required with minimal advance notice to support business needs.
Preferred Background
  • High school graduate, vocational school graduate, or equivalent.
  • 1 year of experience in a pharmaceutical or cGMP regulated environment.
  • Working knowledge of Microsoft applications and SAP.
  • Prior production experience.
  • Experience working in a LEAN packaging environment.
  • Knowledge of cGMPs and FDA policies/procedures.
Benefits

BioSpace, Inc. offers a robust total rewards program, including equity, an annual cash bonus program, a 401(k) plan with a generous company match, and a benefits package designed to support employees with great healthcare, family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement, and support for caregiving needs. Our target base pay hiring range for this position is $30.50 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills, and knowledge.

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