Validation Engineer

Yoh, A Day & Zimmermann Company; Noblesville (IN); On-site; USD 80,000 - 86,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

Life & Disability Insurance

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Referral Bonus Programs

Certification and training

Equal Opportunity Employer

Job summary

Yoh is seeking a Validation Engineer for a pharmaceutical manufacturing client in Noblesville, IN. The role focuses on hands-on validation activities for CIP systems, sterile processes, and associated utilities within a GMP environment.

Responsibilities include leading validation lifecycle activities, coordinating cross-functionally, and producing validation reports. Familiarity with temperature mapping tools and regulatory requirements is required. Competitive benefits apply.

Qualifications

• Bachelor's degree in life sciences or engineering required; experience may substitute for degree.
• 3+ years of relevant validation experience required.
• 2+ years of validation experience with sterile processes required.
• Working knowledge of global cGMPs.

Responsibilities

• Lead validation activities across URS, criticality assessments, risk assessments, FAT/SAT, IQ/OQ/PQ, CSV, CV, PV, and re-qualifications for equipment, facilities, and utilities.
• Coordinate with R&D, Operations, lab and Engineering to estimate resources, schedules and risks.
• Create validation summary reports, including exceptions or deviations as needed.
• Generate and review Change Control documents and site validation documentation.
• Support internal and external audits with expert insights and issue resolution.

Skills

Project management

Cross-functional collaboration

Validation lifecycle

cGMP knowledge

Documentation

Audit support

Temperature mapping equipment

Education

Bachelor's degree in life sciences or engineering

Tools

Kaye Validator

ValProbe

Ellab

Job description

Yoh is hiring a Validation Engineer for our Pharmaceutical Manufacturing client in Noblesville, Indiana.

Job Functions:

• Hands on experience or knowledge of Cleaning Visual Inspection, Swabbing and rinse sampling of CIP systems or manufacturing equipment.
• Support authoring and execution of validation life cycle activities such as URS, Criticality Assessments, Risk Assessments, FAT, SAT, IOPQ, PPQ, CSV, CV, PV, Periodic Reviews and re-qualifications) for new and existing equipment, facilities and utilities in a pharmaceutical manufacturing and packaging environment.
• Drive project management efforts for validation activities including project resource estimating, scheduling, risk assessment and overall coordination with cross functional teams including but not limited to: R&D, Operations, laboratory and Engineering.
• Collect and review validation data and create validation summary reports including generation of exceptions or deviations, as needed.
• Hands on experience with Kaye Validator, ValProbe, or Ellab temperature mapping equipment
• Generate and review Change Control documents, site validation documents, and site Standard Operating Procedures.
• Maintain current knowledge of federal and state regulations regarding validation and cGMPs and proactively champion validation initiatives to meet same.
• Assist in training and development of validation personnel.
• Perform periodic SOP review and revisions to assure alignment with corporate and regulatory requirements.
• Coordinate or author investigations to determine root causes and actively participate to develop and propose changes to prevent reoccurrence of issues.
• Support the validation function during internal and external audits, providing expert insights and quick resolution to observations or deviations.

Education and Experience Requirements:

• Bachelors Degree in related life sciences or Engineering required. Work experience will be considered in lieu of degree.
• Threeor more years of relevant experience required.
• Two 2years of validation experience with sterile processes required.
• Working knowledge of global cGMPs.
• Validation Life Cycle and pharmaceutical manufacturing requirements.
• Familiarity with the Sterile manufacturing and packaging facilities and operations.
• Familiarity with Radiopharmaceutical processing is highly preferred.

#IND-SPG

Estimated Min Rate: $80000.00

Estimated Max Rate: $86000.00

What’s In It for You?

Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.