INCOG BioPharma Services
Manufacturing Engineering Technician, 3rd shift
INCOG BioPharma Services, Fishers, Indiana, us, 46085
Description
Manufacturing Engineering Technician
About This Role
We are seeking a highly motivated Manufacturing Engineering Technician with subject matter expertise in sterile pharmaceutical manufacturing processes and industrial mechanics. This hands-on role combines technical excellence with leadership opportunities in our state-of-the-art GMP facility.
What You'll Do
As our Manufacturing Engineering Technician, you'll serve as a technical leader and problem-solver, driving continuous improvement initiatives while ensuring operational excellence. You'll work directly with cutting-edge sterile manufacturing equipment and mentor team members in a collaborative, fast-paced environment.
Key Responsibilities
Technical Leadership & Operations
• Serve as SME for filling, formulation, inspection, packaging equipment, and supporting systems • Perform duties in Grade C, D, and non-classified cleanrooms with aseptic manipulations in Grade A isolators • Lead manufacturing processes including changeovers, setup, and startup operations • Execute preventative and corrective maintenance activities with precision and efficiency
Problem-Solving & Continuous Improvement
• Diagnose and resolve mechanical issues with timely, effective solutions • Identify and implement process improvements in collaboration with cross-functional teams • Evaluate and enhance efficiency of manufacturing, inspection, and packaging equipment • Apply design thinking and Good Engineering Practices (GEP) to drive operational excellence
Project & Vendor Management
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) • Partner with vendors and suppliers to define requirements and functional specifications • Support equipment validation activities and process improvements
Team Leadership
• Mentor and motivate personnel to drive timely production activities • Inspire problem-solving and solution-driven thinking across teams • Demonstrate leadership skills in high-pressure manufacturing environments
What We're Looking For
Required Qualifications
• High School diploma • 5+ years of mechanical, electro-mechanical, installation, operation, or manufacturing maintenance experience, OR 3+ years of direct pharmaceutical/sterile manufacturing experience • Strong mechanical aptitude and adaptability to changing manufacturing needs • Experience with GMP manufacturing, pharmaceuticals/biologics, or highly regulated industries • Knowledge of aseptic filling, sterile manufacturing, and engineering principles
Preferred Qualifications
• Associate's or Bachelor's degree in biological sciences, biotechnology, engineering, or related field • Lean Six Sigma Certification • Practical expertise with cGMP manufacturing and regulatory requirements • Experience with biotechnology products, aseptic processing (fill and finish), and process development
What We Offer
Join INCOG Biopharma Services and be part of a team that's "All In" on delivering quality products that make a difference in patients' lives. You'll work in a collaborative environment where you can "Lean Forward" in your career while helping us "Pull for the Team."
This position requires flexibility to work various shifts to ensure continuous facility coverage.
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.
By submitting your resume and details, you are declaring that the information is correct and accurate.
Manufacturing Engineering Technician
About This Role
We are seeking a highly motivated Manufacturing Engineering Technician with subject matter expertise in sterile pharmaceutical manufacturing processes and industrial mechanics. This hands-on role combines technical excellence with leadership opportunities in our state-of-the-art GMP facility.
What You'll Do
As our Manufacturing Engineering Technician, you'll serve as a technical leader and problem-solver, driving continuous improvement initiatives while ensuring operational excellence. You'll work directly with cutting-edge sterile manufacturing equipment and mentor team members in a collaborative, fast-paced environment.
Key Responsibilities
Technical Leadership & Operations
• Serve as SME for filling, formulation, inspection, packaging equipment, and supporting systems • Perform duties in Grade C, D, and non-classified cleanrooms with aseptic manipulations in Grade A isolators • Lead manufacturing processes including changeovers, setup, and startup operations • Execute preventative and corrective maintenance activities with precision and efficiency
Problem-Solving & Continuous Improvement
• Diagnose and resolve mechanical issues with timely, effective solutions • Identify and implement process improvements in collaboration with cross-functional teams • Evaluate and enhance efficiency of manufacturing, inspection, and packaging equipment • Apply design thinking and Good Engineering Practices (GEP) to drive operational excellence
Project & Vendor Management
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) • Partner with vendors and suppliers to define requirements and functional specifications • Support equipment validation activities and process improvements
Team Leadership
• Mentor and motivate personnel to drive timely production activities • Inspire problem-solving and solution-driven thinking across teams • Demonstrate leadership skills in high-pressure manufacturing environments
What We're Looking For
Required Qualifications
• High School diploma • 5+ years of mechanical, electro-mechanical, installation, operation, or manufacturing maintenance experience, OR 3+ years of direct pharmaceutical/sterile manufacturing experience • Strong mechanical aptitude and adaptability to changing manufacturing needs • Experience with GMP manufacturing, pharmaceuticals/biologics, or highly regulated industries • Knowledge of aseptic filling, sterile manufacturing, and engineering principles
Preferred Qualifications
• Associate's or Bachelor's degree in biological sciences, biotechnology, engineering, or related field • Lean Six Sigma Certification • Practical expertise with cGMP manufacturing and regulatory requirements • Experience with biotechnology products, aseptic processing (fill and finish), and process development
What We Offer
Join INCOG Biopharma Services and be part of a team that's "All In" on delivering quality products that make a difference in patients' lives. You'll work in a collaborative environment where you can "Lean Forward" in your career while helping us "Pull for the Team."
This position requires flexibility to work various shifts to ensure continuous facility coverage.
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.
By submitting your resume and details, you are declaring that the information is correct and accurate.