Senior Validation Engineer

INCOG BioPharma; Fishers (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Validation Engineer to join their dynamic team in Fishers, Indiana. This role is crucial for ensuring compliance and quality in a sterile injectables manufacturing environment. The ideal candidate will have a robust background in validation, with hands-on experience in qualification processes and a deep understanding of GMP standards. You will collaborate with various teams to drive validation efforts and influence outcomes positively, all while adapting to the fast-paced demands of the industry. If you are passionate about quality assurance and thrive in a collaborative setting, this opportunity is perfect for you.

Qualifications

• 5-8 years of experience in validation or related discipline.
• Strong understanding of GMP and regulatory compliance.

Responsibilities

• Perform qualification activities on utilities, equipment, and laboratory systems.
• Support validation oversight for capital expansion projects.

Skills

Validation Expertise

GMP Experience

Risk Assessment

Cross-Functional Collaboration

Education

Bachelor's degree in STEM

Master's degree in STEM

Tools

Computer System Validation

Cleaning Validation

Sterilization Techniques

Job description

INCOG BioPharma is seeking a highly motivated Senior Validation Engineer with validation expertise to join our team. The Senior Validation Engineer is a key individual contributor role within the INCOG BioPharma Validation Department. The Senior Validation Engineer is responsible for understanding and implementing validation requirements for a sterile injectables manufacturing facility. The ideal candidate has subject matter expertise and practical experience in qualification and validation.

The Senior Validation Engineer will partner with internal customers to meet the needs of client projects, facility upgrades, capital expansion projects, and laboratory systems. They will possess a demonstrated ability to influence positive outcomes without direct reporting authority. Additionally, they must thoroughly understand and be able to adapt to the changing needs of a manufacturing environment.

Essential Job Functions:

1. Perform Qualification activities on utilities, equipment and laboratory systems. This includes, but is not limited to, clean utilities, autoclave, washer, filler, laboratory instruments, controlled temperature units, etc.
2. Interact with clients to provide validation support including but not limited to, customer product launches, new equipment qualifications.
3. Support and provide validation oversight for capital expansion projects/build outs.
4. Take ownership in the development and modification of Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for equipment validation policies, standards, procedures, and templates.
5. Review facility changes and provide input on re-validation and re-qualification of equipment.
6. Assess risks involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables.
7. Engage in a cross functional team and work closely with other supporting groups including Engineering and Operations to support and monitor validation and process improvement efforts.
8. Conduct validation qualifications in accordance with all applicable protocols and identify associated protocol excursions.
9. Identify industry trends in validation and expectations of regulatory agencies and propose program modifications as appropriate to align with current requirements.

Special Job Requirements:

• Bachelor’s degree or higher in STEM discipline.
• 5-8 years of experience in Validation or related discipline.
• 4+ years GMP experience required or other regulated industry.
• Physically capable of working onsite.

Additional Preferences:

• Master's degree or higher preferred.
• Computer System Validation experience preferred.
• Cleaning Validation experience preferred.
• VHP & Steam Sterilization experience preferred.

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.

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