Overview :
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Job Title : Packaging Operator III
Location : Tampa, FL, 33634
Duration : 12 Months
Job Type : Temporary Assignment
Work Type : Onsite
Shift : 1st Shift
Summary
The Production Line Operator is responsible for managing and monitoring pharmaceutical production lines to meet established schedules in compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), and safety regulations. This role ensures product quality, operational efficiency, and adherence to all applicable regulatory standards while maintaining a clean, safe, and compliant work environment.
Key Responsibilities
- Operate and monitor manual or automated high-speed equipment for assembly, filling, packaging, and labeling of pharmaceutical products.
- Ensure production activities meet SOP, cGMP, and safety standards at all times.
- Conduct equipment set-ups, in-process checks, changeovers, and line clearances according to established procedures.
- Complete and verify batch records, logbooks, and other documentation accurately and in a timely manner.
- Inspect, accept, or reject products according to quality and compliance standards.
- Maintain cleanliness of production and packaging areas in alignment with SOP and cGMP requirements.
- Coordinate with maintenance teams to resolve mechanical or quality-related issues promptly.
- Support continuous improvement initiatives including waste reduction, process efficiency, and 5S practices.
- Participate in team meetings and training sessions; provide feedback and process improvement ideas.
- Train or assist less experienced team members when required.
- Ensure compliance with all relevant regulatory, environmental, and safety requirements (FDA, EC, ISO 13485, OSHA, etc.).
- Perform other duties or temporary assignments as directed by management.
Required Qualifications
High School diploma or equivalent.Minimum of 1 year in a manufacturing or high-speed production environment.Experience in aseptic or pharmaceutical manufacturing environments.Prior exposure to GMP-regulated operations.SAP or equivalent ERP system experience.Understanding of ISO 13485 and other medical device manufacturing standards.Demonstrated initiative in process improvement and lean manufacturing practices.Experience mentoring or training junior staff.Familiarity with GMP-regulated operations preferred.Basic knowledge of Microsoft Office; capable of performing data entry and record maintenance.Effective operation of manual and automated production equipment.Strong hand-eye coordination and manual dexterity.Excellent math skills (addition, subtraction, multiplication, division).Attention to detail and accuracy in documentation.Ability to interpret and follow detailed written and verbal instructions.Strong teamwork and communication skills.Physical Requirements :
Ability to stand / walk continuously and lift up to 40 lbs (men) or 35 lbs (women).Frequent bending, climbing, squatting, and reaching.Ability to work any shift (up to 12 hours) as required.Adherence to gowning and controlled-environment protocols (hairnets, beard covers, safety shoes, goggles, etc.).Regulatory Compliance
All employees are required to adhere to applicable regulatory standards including, but not limited to :FDA, EC, ISO 13485, OSHA, EPA, DOT, EEOC, and ADA regulations.Company policies on Environmental, Health & Safety (EHS), cGMP, and Quality Management Systems.TekWissen Group is an equal opportunity employer supporting workforce diversity.