EmployIndy
  • Immediate Opportunities - Life Sciences
  • Indianapolis, IN, USA
  • Full Time
  • Full package of benefits

Production IV Filling – NW Indy

EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis.  Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking candidates for the Production IV Filling position.

 

Position Overview:

This is a senior level position in the aseptic fill group. The employee will utilize experience and training to manufacture pharmaceuticals in a strictly controlled GMP environment. The employee will spend approximately 80% of time performing activities supporting aseptic fill/finish operations and 20% of time performing departmental administrative activities. The employee will act as primary backup for the Supervisor of the Filling/Packaging group.

 

Major Position Activities & Responsibilities:

  • Have demonstrated expertise in one or more of the following functional areas: Previous work experience in Clean room/Aseptic environments, Equipment Preparation, Stopper Preparation, Inspection (semi-automated and manual), Packaging Operations, Sanitization of Classified Areas and Operation of Autoclaves.
  • Must be certified and maintain certification for entry into the Aseptic Core.
  • The employee will be required to oversee activities of other members of the Manufacturing team, taking responsibility for the process results.
  • Execute tasks/operations with minimal supervision.
  • Coordinate with support group, issuance of material and components.
  • Conduct and author QTS nonconforming product investigations, identify and implement corrective actions.
  • Write and revised Master Production Control Records and Standard Operating Procedures.
  • Perform final batch record reviews prior to QA review.
  • Liase with Technical Support and Engineering functions in support of process investigations, process improvement initiatives, and new process development projects.
  • Act as primary backup for Supervisor of Filling/Packaging group.
  • As a part of the employee's job requirements, the employee may be required to handle wastes including hazardous wastes.  And, the employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
  • Must immediately notify supervisor if affected by infectious disease or open lesions on body, as individuals are not permitted to enter manufacturing areas or handle product if these conditions exist. 

 

Background Qualifications:

  • 4-year college degree plus 1 or more years of relevant experience or 2-year degree plus 4 years relevant experience, or 10+ years of relevant experience.  Degrees in a technical area of study (i.e. biology, chemistry, engineering, etc) are preferred.
  • Minimum of five years of experience using current Good Manufacturing Practices (GMP) within an aseptic environment of a regulated manufacturing facility (pharmaceutical/biotech/diagnostic industry).
  • Strong verbal and written communication skills to read, comprehend, discuss and write detailed GMP documentation (batch record instructions, Standard Operating Procedures, etc.).
  • As persons in this role are engaged in the open manufacture of medicinal products, individuals must not be affected by an infectious disease nor have open lesions on any exposed surface of the body.
  • Must possess adequate working knowledge of arithmetic functions to accurately perform or check calculations required in the product documentation.
  • Possess presentation and assertiveness skills adequate to lead and train others.
  • Consistent positive influence on co-workers, leading by example.
  • Demonstrated commitment to high quality work.
  • Initiative and experience to anticipate area needs and do more than required.
  • Demonstrated good judgment regarding utilization of company resources.
  • Catalyst for change and continuous improvement/development.
  • Leadership experience in training/directing others preferred.
  • Demonstrated mechanical aptitude.
  • Willing to encourage and correct compliance according to Company goals and objectives.
  • Ability to troubleshoot, identify problems, and propose solutions.
  • While performing the duties of this job, the employee is regularly required to use their hands and arms. The employee is frequently required to stand. The employee is occasionally required to sit; walk; stoop, kneel, bend, crouch, or crawl, talk or hear. The employee must regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision and peripheral vision.
  • Computer skills in Microsoft Office such as Word and Excel are required.

 

 Exelead




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