Manufacturing Specialist - Filling, 3rd shift

INCOG BioPharma Services; Fishers (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

INCOG BioPharma is seeking a highly motivated Manufacturing Specialist with SME capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. This 3rd shift role (Sun-Thu, 11:00 PM–7:30 AM) is a key technical position within INCOG BioPharma Operations, requiring experience in GMP manufacturing or related regulated environments.

You will follow procedures, operate sterile filling equipment, document batch records, support validations, and train others in

Qualifications

• High School diploma and 3 years of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical filling equipment.
• Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.
• BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish) general Good Manufacturing Practices (cGMP).
• 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.

Responsibilities

• Follow production and manufacturing procedures.
• Perform duties in Grade C, D, and controlled non-classified cleanrooms.
• Perform aseptic manipulations within Grade A isolators.
• Perform cleaning and sanitization, equipment preparation, and aseptic filling duties as needed.
• Safely operate production equipment including setup and changeovers.
• 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.
• Collaborate and communicate with cross functional teams.
• Work flexible hours to ensure production facility coverage.

Skills

MS Office

MS Word

MS Excel

Windows

Communication skills

GMP knowledge

Education

BS in biological sciences/biotechnology

Tools

ERP systems

Inventory management systems

Job description

INCOG BioPharma is seeking a highly motivated individual with subject matter expert (SME) capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. The Manufacturing Specialist is a key technical role within INCOG BioPharma Operations. The ideal candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, or within highly regulated industries.

This is a 3rd shift role with typical hours Sunday-Thursday from 11:00PM-7:30AM.

Essential Job Functions

• Follow production and manufacturing procedures.
• Perform duties in Grade C, D, and controlled non-classified cleanrooms.
• Perform aseptic manipulations within Grade A isolators.
• Perform cleaning and sanitization, equipment preparation, and aseptic filling duties as needed.
• Safely operate production equipment including setup and changeovers.
• 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.
• Collaborate and communicate with cross functional teams.
• Work flexible hours to ensure production facility coverage.

Job Requirements

• High School diploma and 3 years of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical filling equipment.
• Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.

Job Preferences

• BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish) general Good Manufacturing Practices (cGMP).
• 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.

Additional info about INCOG BioPharma Services

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

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