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Process Operator - 1st Shift

Scientific Protein Laboratories

Waunakee, WIOnsitePosted 15 days ago
Full TimeEntry LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

Our Process Operator is responsible for learning, under direct supervision, the activities necessary to produce SPL products following current Manufacturing Instructions (MIs) and current Good Manufacturing Practices (cGMPs).

Job description

Responsibilities

  • Follows written procedures required for the production of SPL specialty products according to current Manufacturing Instructions (MI's), Good Manufacturing Practices (GMP's), Good Documentation Practices (GDP's) and Standard Operating Procedures (SOP's).
  • Performs activities necessary to manufacture products. These activities may include but are not limited to solvent handling, washing and sanitizing equipment and work areas, and process equipment assembly and teardown.
  • Must be able to exercise good judgment to accomplish goals to ensure success while manufacturing a costly product.
  • Adheres to established work schedules in a consistently reliable manner and performs job responsibilities and delivers work products on a dependable and timely basis.
  • Must be knowledgeable on basic mathematics and be able to use a calculator to perform basic calculations.
  • Able to perform a variety of tasks while exercising some degree of creativity and latitude to accomplish goals.
  • Will work with acids, caustics, solvents, and use PPE. Utilizes good housekeeping practices to ensure work areas are neat and sanitary.
  • Follows all SPL safety practices and procedures.

Requirements

  • Education: High School Diploma or G.E.D.
  • Entry-level candidates with a strong work ethic and willingness to learn will be considered.
  • Ability to follow detailed written Manufacturing Instructions (MIs), Standard Operating Procedures (SOPs), and other controlled documentation.
  • Basic understanding of Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs), or the ability to learn and apply these standards.
  • Ability to work safely with chemicals including acids, caustics, and solvents while following established safety procedures.
  • Ability to assemble, disassemble, clean, and sanitize manufacturing equipment.
  • Ability to work in a manufacturing environment with exposure to varying temperatures, noise levels, and chemical processing operations.
  • Strong attention to detail with the ability to accurately complete production records and documentation.
  • Ability to successfully complete required training and qualification programs.
  • Must be able to lift up to 90 lbs.
  • Ability to use personal protective equipment as required.
  • Ability to work a 12 hour shift.
  • Schedule: 1st shift, 4am- 4pm, Wednesday, Thursday and every other weekend (Friday – Sunday).

Preferred

  • Associate degree or coursework in Biotechnology, Life Sciences, Chemistry, Manufacturing Technology, or a related field.
  • 2+ years of experience in manufacturing, pharmaceutical, biotechnology, food processing, chemical processing, or regulated production environments.

Requirements

  • High School Diploma or G.E.D.
  • Entry-level candidates with a strong work ethic and willingness to learn will be considered.
  • Ability to follow detailed written Manufacturing Instructions (MIs), Standard Operating Procedures (SOPs), and other controlled documentation.
  • Basic understanding of Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs), or the ability to learn and apply these standards.
  • Ability to work safely with chemicals including acids, caustics, and solvents while following established safety procedures.
  • Ability to assemble, disassemble, clean, and sanitize manufacturing equipment.
  • Ability to work in a manufacturing environment with exposure to varying temperatures, noise levels, and chemical processing operations.
  • Strong attention to detail with the ability to accurately complete production records and documentation.
  • Ability to successfully complete required training and qualification programs.
  • Must be able to lift up to 90 lbs.
  • Ability to use personal protective equipment as required.
  • Ability to work a 12 hour shift.
  • Schedule: 1st shift, 4am- 4pm, Wednesday, Thursday and every other weekend (Friday – Sunday).
  • Preferred: Associate degree or coursework in Biotechnology, Life Sciences, Chemistry, Manufacturing Technology, or a related field.
  • Preferred: 2+ years of experience in manufacturing, pharmaceutical, biotechnology, food processing, chemical processing, or regulated production environments.

Benefits

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Life Insurance
  • AD&D Insurance
  • Short-Term Disability
  • Long-Term Disability
  • Health Savings Account
  • Flexible Spending Account
  • Employee Assistance Program
  • Paid Vacation
  • Paid Holidays
  • 401(k)
  • Advancement Opportunities
  • Team-Oriented Environment
  • Community Involvement
  • Company Events

Company overview

Scientific Protein Laboratories (SPL) is a leading global supplier of high-quality active pharmaceutical ingredients (APIs) with over four decades of experience in the pharmaceutical manufacturing industry. Founded in 1976 in Waunakee, Wisconsin, the company specializes in cGMP biopharmaceutical manufacturing and is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. SPL serves pharmaceutical, veterinary, and food industries worldwide, operating manufacturing facilities in both Waunakee, Wisconsin and Sioux City, Iowa. The company focuses on extracting, isolating, and purifying naturally-derived materials from animal and plant sources, with particular expertise in porcine-sourced starting materials. As a subsidiary of Shenzhen Hepalink Pharmaceutical since 2014, SPL maintains a strong commitment to regulatory compliance and quality assurance, operating strictly in accordance with FDA's cGMP requirements while providing comprehensive regulatory support to its global customer base.

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