Senior Validation Engineer

INCOG BioPharma Services; Fishers (IN); On-site; USD 95,000 - 135,000; Full time

Job summary

INCOG BioPharma is seeking a Senior Validation Engineer to lead qualification and validation for a sterile injectables facility. You will partner with clients, operations and engineering to ensure compliant product launches and capital projects.

This role requires 5–8 years in validation, GMP experience, and a Bachelor's in STEM. Onsite work in Fishers, IN is expected with collaboration across teams.

Qualifications

• 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.

Responsibilities

• Perform Qualification activities on utilities, equipment and laboratory systems.
• Interact with clients to provide validation support including product launches and new equipment qualifications.
• Support and provide validation oversight for capital expansion projects or build outs.
• Develop and modify SOPs, WIs and templates for equipment validation policies and procedures.
• Review facility changes and input on re-validation and re-qualification of equipment.
• Assess risks in processing steps and develop validation requirements and deliverables.
• Collaborate with Engineering and Operations to monitor validation and process improvements.
• Conduct validation qualifications in line with applicable protocols and identify excursions.
• Track industry trends and adjust programs to meet regulatory expectations.

Skills

Validation

GMP experience

Qualification

Regulatory experience

Education

Bachelor's degree in STEM

Master's degree (preferred)

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 outcome 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

• 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.
• Interact with clients to provide validation support including but not limited to, customer product launches, new equipment qualifications.
• Support and provide validation oversight for capital expansion projects/build outs
• 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
• Review facility changes and provide input on re-validation and re-qualification of equipment
• Assess risks involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables
• 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
• Conduct validation qualifications in accordance with all applicable protocols and identify associated protocol excursions.
• 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 experiencepreferred
• Cleaning Validation experience preferred
• VHP & Steam Sterilization experience preferred

INCOG is hiring for both Validation Engineer and Senior Validation Engineer opportunities. The final level will be determined based on the candidate’s qualifications, relevant industry experience, technical expertise, and demonstrated independence. Candidates may be considered for the Validation Engineer or Senior Validation Engineer level as appropriate.

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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