Packaging Equipment Specialist, 2nd Shift

INCOG BioPharma Services; Fishers (IN); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Paid time off based on tenure

401(k) plan with company match

Choice of health & wellness plans

Pet insurance option

Dental & vision care

FSA and HSA programs

Job summary

INCOG BioPharma Services in Fishers, Indiana is seeking a motivated Equipment Specialist with expertise in sterile pharmaceutical manufacturing. The role focuses on setting up and operating production equipment and involves troubleshooting and continuous improvement of processes.

The ideal candidate has a strong mechanical aptitude, 7+ years of GMP experience, and a High School diploma. Benefits include paid time off, 401(k) plan with company match, and health & wellness plans.

Qualifications

• 7 years of GMP pharmaceutical experience with equipment.
• Knowledge of pharmaceutical manufacturing and aseptic processing.
• Ability to apply concepts such as fractions and percentages.

Responsibilities

• Set up and operate production equipment safely.
• Lead batch start-up activities and production cycles.
• Document data and complete batch records accurately.
• Provide technical support to manufacturing activities.

Skills

Mechanical aptitude

Troubleshooting skills

Communication skills

Knowledge of cGMP

Education

High School Diploma

BS in biological sciences/biotechnology

Tools

MS Office

ERP 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 of inspection and packaging equipment. The Equipment Specialist has 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.

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 troubleshooting 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.

The ideal candidate must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment while providing high level support to the process engineering and operations team in troubleshooting, repair and preventative maintenance of manufacturing equipment and processes.

Essential Job Functions

• Follow production and manufacturing procedures.
• Perform duties in controlled non-classified inspection and packaging areas.
• 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 inspection/packaging operations, 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 Inspection and Packaging 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.

Special Job Requirements

• 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.

Additional Preferences

• BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience preferred.
• 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.

INCOG’s Benefits

• Paid time off, based on tenure.
• 9 observed holidays + 2 floating holidays.
• Choice to elect for pet insurance.
• 401(k) plan with company match up to 3.5% of salary, vested immediately.
• Choice of health & wellness plans.
• FSA and HSA programs.
• Dental & vision care.

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.