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We are currently looking for:

Aseptic Clinical Production Technician

IRISYS LLC has an open temporary position for an Aseptic Clinical Production Technician. Candidate should have working experience in aseptic production of injectables and other sterile pharmaceutical products.

Primary Responsibilities:

  • Verifies that correct components are used.
  • Follows all established procedures and policies.
  • Performs necessary quality checks relative to the operation.
  • Inspects components, materials, and product to ensure any required equipment/material is present with proper identification, acceptable quality, and correct quantity.
  • Ensures manufacturing equipment has necessary supplies and materials for the operation.
  • Report quality deviations to lead person/supervisor and assists with resulting investigations.
  • Assist with Scientists in implementation of corrective and/or preventive actions.
  • Ensure facility and equipment is maintained in a clean and organized fashion.
  • Assist in set up of manufacturing suites and line clearances per standard operating procedures.
  • Review and/or complete production documentation (i.e. Master Batch Records, Specifications) in a timely fashion and with a high degree of accuracy in accordance with company policies/procedures and cGMPs/GDPs.
  • Maintains work area in a neat and orderly condition.
  • Performs minor troubleshooting and/or works with Facilities to resolve machine stoppages and quality issues.
  • Ability to read, interpret, and apply company policies, procedures, and cGMPs relative to job function.

Knowledge, Skills and/or Abilities:

  • Experience with working in Aseptic Suites in a cGMP environment
  • Familiarity with cGMP/FDA regulations
  • Experience with production of bulk solutions up for sterile products, sterile filtration, and aseptic fill operations.
  • Proficient in Microsoft Office
  • Good Communication Skills

Required Experience:

Bachelor’s or higher degree in chemistry, biochemistry, physical chemistry, or another related field is preferred.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

IRISYS, LLC is an Equal Opportunity employer – M/F/Veteran/Disability – committed to the hiring, advancement, and fair treatment of all individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other protected status as designated by federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Aseptic Clinical Production Technician ” in the subject line of the email.

Aseptic Clinical Production Supervisor

IRISYS LLC has an open temporary position for an Aseptic Clinical Production Supervisor. Candidate should have working experience in aseptic production of injectables and other sterile pharmaceutical products.

Primary Responsibilities:

  • Verifies that correct components are used.
  • Follows all established procedures and policies.
  • Performs necessary quality checks relative to the operation.
  • Inspects components, materials, and product to ensure any required equipment/material is present with proper identification, acceptable quality, and correct quantity.
  • Ensures manufacturing equipment has necessary supplies and materials for the operation.
  • Report quality deviations to lead person/supervisor and assists with resulting investigations.
  • Assist with Scientists in implementation of corrective and/or preventive actions.
  • Ensure facility and equipment is maintained in a clean and organized fashion.
  • Assist in set up of manufacturing suites and line clearances per standard operating procedures.
  • Review and/or complete production documentation (i.e. Master Batch Records, Specifications) in a timely fashion and with a high degree of accuracy in accordance with company policies/procedures and cGMPs/GDPs.
  • Maintains work area in a neat and orderly condition.
  • Performs minor troubleshooting and/or works with Facilities to resolve machine stoppages and quality issues.
  • Ability to read, interpret, and apply company policies, procedures, and cGMPs relative to job function.

Knowledge, Skills and/or Abilities:

  • Experience with working in Aseptic Suites in a cGMP environment
  • Familiarity with cGMP/FDA regulations
  • Experience with production of bulk solutions up for sterile products, sterile filtration, and aseptic fill operations.
  • Proficient in Microsoft Office
  • Good Communication Skills

Required Experience:

Bachelor’s or higher degree in chemistry, biochemistry, physical chemistry, or another related field is required.  Experience in lieu of higher degree combined with a bachelors will be considered.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

IRISYS, LLC is an Equal Opportunity employer – M/F/Veteran/Disability – committed to the hiring, advancement, and fair treatment of all individuals. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or any other protected status as designated by federal, state or local law.

To Apply: If you are interested in being part of the IRISYS LLC team, please email your CV and Cover Letter directly to HR@irisys.com. Please put the job reference “Aseptic Clinical Production Supervisor” in the subject line of the email.