Production Technician - Isolator

Production Technician II (mid-level) – Indianapolis, IN

Direct message the job poster from Lance Soft, Inc. This is a mid-level position in the aseptic filling group within the Manufacturing department. It requires experience and training to manufacture pharmaceuticals in a strictly controlled GMP environment. The employee will progress through a number of job functions and demonstrate increasing skill levels while showing leadership capabilities.

Must have previous isolator experience. HM seeks a candidate with pharmaceutical manufacturing experience. This position has exposure to SIP
100. PPE will be worn and provided by EMD.

• Job Title – Production Technician II (mid-level)
• Location – 6925 Guion Rd, Indianapolis, IN, USA, IN-46268
• Duration – 12 months (temp to perm potential)
• Shift & Schedule – 1st shift (07:00 – 15:30), Mon to Fri
• Interviews – virtual or onsite
• Department – Manufacturing

• Become certified for entry into the GMP cleanroom space to perform sanitization, stock/replenish supplies, equipment setup, and all related aseptic filling operations.
• Execute aseptic fill processes using batch records and SOPs.
• Verify calibration of related equipment and sanitization of supplies to support production.
• Increase level of competency in manufacturing area procedures; assigned duties include Aseptic and clean room areas, Component Preparation, Filling and Capping.
• Learn functions to work in the Fill suite and operate the associated equipment.
• Perform tasks with minimal supervisor direction.
• Provide training for new team members.
• Understand the manufacturing schedule and coordinate tasks to achieve the schedule.
• Provide floor leadership in the absence of a supervisor or PT3 technicians.
• Transport and/or dispose of hazardous chemicals.
• Perform all other duties as assigned.
• Must immediately notify supervisor if affected by an infectious disease or open lesions on the body, as individuals are not permitted to enter manufacturing areas or handle products if these conditions exist.

• This position has no direct reports.

• High school diploma or the equivalent. College coursework preferred.
• Minimum 3-5 years, including relevant aseptic filling experience in a cGMP pharmaceutical manufacturing facility.
• Working knowledge and understanding of GMP compliance regulations.
• Knowledge and experience in the aseptic filling process, along with equipment cleaning, preparation, and assembly. Experience in stopper prep, capping, and packaging preferred.
• Must not be affected by an infectious disease nor have open lesions on any exposed surface of the body.
• Ability to comprehend and follow detailed procedural instructions in written and verbal form.
• Adequate working knowledge of arithmetic to perform or check calculations in product documentation.
• Physical requirements:
  
  frequently stand, occasionally sit/stoop/kneel/bend/crouch/crawl; lift up to 50 pounds; may involve color/near vision and other sight requirements.
• Fluent English (written and verbal) to read, comprehend, and communicate GMP documentation and SOPs.
• Computer skills in Microsoft Office (Word, Excel) are a plus.

• Management and Manufacturing

• IT Services and IT Consulting

Note:

This description retains original role language and requirements while removing extraneous boilerplate. It focuses on responsibilities, qualifications, and work expectations.