Validation Engineer

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. Estimated Min Rate: $80000.00 Estimated Max Rate: $90000.00 Benefits 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 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. By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: #J-18808-Ljbffr