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Pharmaceutical Formulation Specialist II

2 months ago

South Bend, Indiana, United States Chipton-Ross Full time
Position Overview:

Chipton-Ross is seeking a Formulation Technician II for a contract opportunity. This role involves engaging in the production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms, including tablets, capsules, and granules, while adhering to current Good Manufacturing Practices (cGMP).


Key Responsibilities:
  • Ensure cleanliness of workspaces and facilities with support from designated personnel.
  • Prepare manufacturing areas and components for the execution of Production Batch Records.
  • Act as a verifier on logbooks and related documentation.
  • Execute Production Batch Records and Work Orders efficiently.
  • Work independently and serve as a verifier on at least one line of unit operations.
  • Maintain adequate supplies of Personal Protective Equipment (PPE) and gowning materials in the gowning area.
  • Manage cGMP materials inventory in accordance with relevant Standard Operating Procedures (SOPs).
  • Revise existing SOPs and create new ones as necessary.
  • Conduct equipment qualification processes.
  • Perform cleaning and visual inspections of processing equipment, tools, and utensils, documenting all activities.
  • Ensure proper labeling of all cGMP equipment and components.
  • Fulfill additional technician responsibilities as required.

Required Qualifications:
Minimum of one year of production experience in the pharmaceutical sector is essential. A solid understanding of current Good Manufacturing Practices (cGMP) and familiarity with cGMP documentation, spreadsheets, and software applications is preferred. Experience in the pharmaceutical or biotech fields is highly desirable. A proven ability to produce high-quality work with a strong attention to detail is crucial. Candidates should be capable of managing multiple tasks and adapting to changing priorities in a dynamic manufacturing environment. Proficiency in Microsoft Office Suite (Word and Excel) is required, along with effective written and interpersonal communication skills.

Physical Requirements:
Work Environment:
This position involves the production of pharmaceutical dosage forms within a small-scale manufacturing suite.

The role requires frequent standing for extended periods, along with the physical coordination necessary to navigate office, laboratory, and manufacturing areas. Candidates must be able to stand, walk, stoop, kneel, and crouch for prolonged durations. The ability to lift, carry, and move medium to heavy weights (35-50 pounds) is necessary, as well as dexterity in hands and fingers for prolonged tasks. Visual acuity is needed for using a keyboard, computer monitor, operating laboratory equipment, and reading materials for extended periods. Candidates should also be able to sit, reach with hands and arms, talk, and hear for extended durations.


Educational Background:
An accredited High School Diploma or GED is required. An Associate's degree and/or military experience is preferred.

Work Schedule:
This is a full-time position with standard working hours.