Principal Validation Engineer

incog; Fishers (IN); On-site; USD 120,000 - 165,000; Full time

Job summary

INCOG BioPharma in Fishers, IN is seeking a Principal Validation Engineer to lead validation for sterile manufacturing systems, serialization, ERP/QMS/CMMS/MES, and related automation. You will partner with internal clients on projects, serve as SME during audits, mentor other validation engineers, and develop SOPs and templates to raise standards.

This onsite role requires a STEM degree, 10+ years in validation, 4+ years GMP, and readiness to adapt to a fast-changing manufacturing environment.

Qualifications

• Bachelor’s degree or higher in a STEM discipline
• 10+ years of experience in Validation or related discipline
• 4+ years GMP experience
• Physically capable of working onsite

Responsibilities

• Own validation lifecycle planning for projects such as laboratory instruments and systems, serialization, and computerized systems (ERP, QMS, CMMS, MES).
• Serve as the main point of contact and technical lead for client validation support and guidance.
• Provide validation expertise and oversight for capital expansion projects/build outs.
• Develop SOPs, WIs, and guidelines for validation policies, standards, procedures, and templates.
• Mentor and train validation engineers on validation philosophy, strategy, and execution.
• Represent validation during client audits and regulatory inspections as a SME.

Skills

Validation lifecycle

Technical lead

Risk-based CQV

Mentoring

Regulatory audits

Education

STEM degree

Tools

ERP

QMS

CMMS

MES

Job description

INCOG BioPharma is seeking a highly motivated Principal Validation Engineer with commissioning and qualification of sterile manufacturing systems, combination packaging, or automation, computer system, and software assurance expertise to join our team. The Principal Validation Engineer is a key individual contributor role within the INCOG BioPharma Validation Department. The Principal 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 serialization, automation, and computerized systems following risk-based approaches.

The Principal 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:

• Own validation lifecycle planning for assigned projects such as laboratory instruments and systems, serialization, and computerized systems such as ERP, QMS, CMMS, MES, etc.
• Serve as the main point of contact and technical lead for client validation support and technical guidance.
• Provide validation expertise and oversight for capital expansion projects/build outs.
• Perform process gap assessments and identify continuous improvement opportunities to raise departmental standards.
• Work directly with the Technical Writers as the SME to develop and modify Standard Operating Procedures (SOPs), Work Instructions (WIs) and guidelines for validation policies, standards, procedures, and templates.
• Perform change management impact assessments and set the standard for required validation activities.
• Assess risks involved in processing steps related to systems, developing and/or reviewing validation requirements and design deliverables.
• Identify industry trends in validation and expectations of regulatory agencies and propose program modifications as appropriate to align with current requirements and guidance.
• Mentor and train validation engineers on validation philosophy, strategy, and execution.
• Represent validation during client audits and regulatory inspections as a subject matter expert.

Special Job Requirements:

• Bachelor’s degree or higher in a STEM discipline
• 10+ Years of experience in Validation or related discipline
• 4+ Years GMP experience required
• Physically capable of working onsite

Additional Preferences:

• Master's degree or higher preferred
• 5+ Years CSV/CQV experiencepreferred
• Strong working knowledge of risk-based approaches to CQV of sterile manufacturing equipment and/or CSV/CSA

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.

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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