Sterile Validation Engineer

Job Description

Job Description

Title: Sterile Validation Engineer

Location: Indianapolis, IN or remote in Northeast US

Hire Type: Direct Hire

Compensation: $100,000 - $150,000, based on experience

Benefits: Health, Dental, Vision, 401K, PTO

Must have Skill Set:

Must have proven Validation Engineering experience in a pharmaceutical, biotech, life sciences, or regulated manufacturing environment.

Must have equipment validation experience. Cleanroom validation experience is also acceptable.

Must have proven experience developing and executing decontamination cycle development and validation activities.

Must have hands-on experience with Vaporized Hydrogen Peroxide (VHP/VPHP) systems.

Must have experience with Steris VHP generators or similar VHP generator systems.

Must have experience working in aseptic processing environments, including sterilization of equipment prior to production.

Must have strong pharmaceutical validation documentation experience, including validation protocols, IQ, OQ, PQ documentation, validation reports, and GMP documentation.

Must be willing and able to travel up to 30-50% to customer sites, including local day trips and overnight travel throughout the Northeastern United States.

Overview:

We are seeking an experienced Validation Engineer to support pharmaceutical, biotech, and advanced therapy manufacturing projects. This is a highly hands-on customer-facing role responsible for equipment validation, commissioning, qualification, and decontamination cycle development for aseptic manufacturing systems.

The ideal candidate will have proven experience in Validation Engineering, equipment validation, VHP (Vaporized Hydrogen Peroxide) systems, VHP cycle development, and aseptic processing environments. This individual will work closely with engineering teams and customers to execute Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities while ensuring compliance with pharmaceutical quality and regulatory requirements.

This position requires regular travel to customer sites. Candidates must be comfortable traveling up to 30-50%, including both local day trips and overnight travel throughout the Northeast region.

Job Duties:

Lead and support validation engineering activities for pharmaceutical and biotechnology manufacturing equipment.

Execute and support equipment validation, including FAT, SAT, IQ, OQ, and PQ activities.

Develop, optimize, and validate Vaporized Hydrogen Peroxide (VHP/VPHP) decontamination cycles.

Perform cycle development and support Performance Qualification activities related to VHP sterilization processes.

Work directly with customers and field service teams during equipment installation, commissioning, startup, and qualification.

Support validation activities within aseptic processing environments, ensuring proper sterilization of manufacturing equipment prior to production.

Prepare, review, and execute pharmaceutical validation documentation, including validation protocols, reports, SOPs, deviations, and change control documentation.

Ensure compliance with GMP, regulatory, customer, and internal quality requirements.

Support quality investigations, process improvements, inspections, and corrective actions.

Collaborate with engineering, quality, manufacturing, and customer teams throughout project execution.

Travel to customer facilities for validation, commissioning, startup, and qualification activities (approximately 30-50% travel).

Qualifications:

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline, or equivalent industry experience.

Proven experience in Validation Engineering is required.

Proven experience with equipment validation is required.

Experience with cleanroom validation is acceptable in lieu of equipment validation experience.

Proven experience with Vaporized Hydrogen Peroxide (VHP/VPHP) systems is required.

Experience with Steris VHP generators is strongly preferred.

Proven experience developing decontamination cycles and VHP cycle development is required.

Experience working in aseptic processing and sterile pharmaceutical manufacturing environments is required.

Strong knowledge of pharmaceutical validation principles, GMP requirements, and regulated manufacturing environments.

Experience preparing and executing pharmaceutical documentation, including IQ/OQ/PQ protocols, validation reports, SOPs, and related quality documentation.

Excellent communication, problem-solving, and organizational skills.

Proficiency with Microsoft Office.

Ability and willingness to travel up to 30-50%, including local day travel and overnight travel throughout the Northeastern United States.

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.

You should be proficient in:

• Pharmaceuticals