INCOG BioPharma Services · 8 hours ago
Aseptic Equipment Specialist
Fishers, IN
Full-time
Onsite
Mid, Senior Level
7+ years expINCOG BioPharma is seeking a highly motivated individual with expertise in sterile pharmaceutical manufacturing process controls and industrial automation for the role of Aseptic Equipment Specialist. The primary responsibility includes efficiently and safely setting up and operating production equipment, leading batch activities, and ensuring quality in a GMP environment.
BiopharmaBiotechnologyManufacturingPharmaceutical
Responsibilities
Follow production and manufacturing procedures
Perform duties in Grade C, D, and controlled non-classified cleanrooms
Perform aseptic manipulations within Grade A isolators
Safely operate production equipment including setup and changeovers
Lead batch start up activities and execution of production cycles
Accurately document data and complete batch records
Execute validation/engineering protocols as needed
Train others in various manufacturing tasks including, but not limited to: fill/finish, sanitization, component and equipment preparation
Maintain production equipment and troubleshoot issues
Support equipment optimization efforts and continuous improvement efforts
Resolve issues that arise in day to day running of operation and providing timely responses and solutions
SME for filling equipment and supporting systems
Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation
Provide technical support to manufacturing activities
Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence
Work flexible hours to ensure production facility coverage
Qualification
Required
High School diploma and 7 years of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment
Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required
Must have previous experience with pharmaceutical aseptic processing (fill and finish) cGMP
Preferred
BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment
Excellent communication skills
Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations
Ability to learn and operate a range of industry systems including and not limited to ERP and inventory management systems
Company
INCOG BioPharma Services
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$86.63M2024-05-29Series B· $42.86M
2022-05-10Undisclosed· $15M
2022-05-10Debt Financing
Leadership Team
Tedd Green
Co-founder & Chief Operating Officer
Recent News
Inside INdiana Business
2025-12-16
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