Job TitleSr. Facility Validation EngineerJob Description SummaryPOSITION PURPOSEWe are seeking a Facilities Validation Engineer to join our team to support our Client’s Facilities Operations Quality & Compliance program. The Validation Engineer will be integral to providing subject matter expertise and guidance for all Facilities-related compliance activities.Job DescriptionKEY ACCOUNTABILITIESResponsibilities include, but are not limited to the following:
Assist in the efforts and processes to gather and create Standard Operating Procedure (SOP) requirements or process improvements as it relates to Facilities Operations and compliance.
Drive the day-to-day activities to ensure the accuracy, governance, and maintenance of SOPs. Create Change Orders (COs) as required.
Support the communication and training of SOPs to training and operational teams.
Respond to Corrective & Preventive Action (CAPA) assignments from Quality Assurance.
Manage the end-to-end process for identified exceptions / audit findings to ensure timely completion.
Assist and support CATS web reports, Work Order Notification Forms (WONFs), Quality Data Reviews (QDRs), and Microbiology Investigation Reports (MIRs), utilizing systems such as Viewpoint and Windchill, as well as quality systems.
Manage established user requirements and the execution of validation protocols.
Support and update Quality Plans as they pertain to Facilities Operations.
Additional tasks may be assigned which could include providing surge capacity to complete other routine tasks, as well as to perform special projects outside the normal scope of activities.
JOB REQUIREMENTS & QUALIFICATIONSEducation:
Bachelor’s degree in Life Science, Engineering, or a closely related discipline.
At least 3-4 years of work experience in Quality, Validation, Engineering, Facilities, or related field.
Minimum Requirements:
Proficient with Microsoft Word, Excel and Outlook.
Demonstrated industry experience with regulatory oversight such as laboratory diagnostics, medical devices or pharmaceutical.
Strong understanding of Design Control, Good Documentation Practices (GDP) and current Good Manufacturing Practices (cGMP).
Experience with Viewpoint and/or Windchill, as well as quality systems a plus.
Highly analytical, organized and detail oriented with strong math and communication skills.
Proven record of providing excellent internal and external customer service.
Demonstrated adherence to the highest ethical standards and professionalism.
Familiarity with scientific terminology, regulatory writing styles, and standards & procedures.
Physical Requirements:
Involves work of a general office nature; typically includes extended periods of sitting and/or operation of a computer.
Regularly required to talk, hear, and use hands and fingers to write and type.
Ability to speak clearly so others can understand you.
Ability to read and understand information and ideas presented orally and in writing.
Ability to communicate information and ideas in writing and orally so others will understand.
Regularly required to utilize vision abilities, allowing reading of printed material, graphics, and computer displays.
Cushman & Wakefield also provides eligible employees with an opportunity to enroll in a variety of benefit programs, generally including health, vision, and dental insurance, flexible spending accounts, health savings accounts, retirement savings plans, life, and disability insurance programs, and paid and unpaid time away from work. In addition to a comprehensive benefits package, Cushman and Wakefield provide eligible employees with competitive pay, which may vary depending on eligibility factors such as geographic location, date of hire, total hours worked, job type, business line, and applicability of collective bargaining agreements.The compensation that will be offered to the successful candidate will depend on factors such as whether the position is covered by a collective bargaining agreement, the geographic area in which the work will be performed, market pay rates in that area, and the candidate’s experience and qualifications.The company will not pay less than minimum wage for this role.The compensation for the position is: $119,000.00 - $140,000.00Cushman & Wakefield provides equal employment opportunity. Discrimination of any type will not be tolerated. Cushman & Wakefield is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status or any other characteristic protected by state, federal, or local law.In compliance with the Americans with Disabilities Act Amendments Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a position at Cushman & Wakefield, please call the ADA line at 1-888-365-5406 or email [email protected] . Please refer to the job title and job location when you contact us.INCO: “Cushman & Wakefield”