Equipment Specialist, 2nd shift

INCOG BioPharma Services; Fishers (IN); On-site; USD 65,000 - 85,000; Full time

Job summary

INCOG BioPharma Services in Fishers, IN is seeking an Equipment Specialist to manage production equipment in sterile pharmaceutical manufacturing. The ideal candidate will have 7 years of GMP pharmaceutical experience and strong troubleshooting skills.

This role involves hands-on work, leading batch processes, and ensuring operational excellence. The candidate should possess a mechanical aptitude and be able to train others in manufacturing tasks. All applicants should be aware this position operates in a smoke-free environment.

Qualifications

• 7 years of GMP pharmaceutical experience with operation and maintenance of pharmaceutical GMP equipment.
• Previous experience with pharmaceutical aseptic processing (fill and finish) cGMP required.
• Ability to learn and operate industry systems including ERP and inventory management.

Responsibilities

• Set up and operate production equipment safely and efficiently.
• Perform aseptic manipulations within Grade A isolators.
• Lead batch start-up activities and execute production cycles.
• Train others in various manufacturing tasks.

Skills

GMP pharmaceutical experience

Mechanical aptitude

Troubleshooting skills

Communication skills

Knowledge of MS Office

Education

High School diploma

BS in biological sciences/biotechnology

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 Equipment Specialist is a key technical role within INCOG BioPharma Operations. This candidate must have experience in pharmaceuticals and/or biologics, GMP manufacturing, or within highly regulated industries.

The Equipment Specialist’s primary responsibility is to efficiently and safely set up and operate various pieces of production equipment within the facility. They will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. The ideal candidate should possess a strong mechanical aptitude with strong trouble shooting skills on manufacturing equipment. They should demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and inspire problem solving & solution driven thinking.

This is a 2nd shift role with typical hours Monday-Friday from 3:00PM-11:30PM.

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.
• 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.

Job Requirements

• High School diploma
• 7 years of GMP pharmaceutical experience with the operation 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.
• High School diploma required.

Additional Preferences

• 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.

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.