Job Title
Facilities Validation Engineer
Job Description Summary
We are seeking a Facilities Validation Engineer to join our team to support our Clients 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 Description
KEY ACCOUNTABILITIES
Responsibilities 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.
- 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 & QUALIFICATIONS
Education:
- Bachelors 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).
- 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 is an Equal Opportunity employer to all protected groups including protected veterans and individuals with disabilities. Discrimination of any type will not be tolerated.
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- or email. Please refer to the job title and job location when you contact us.
INCO: Cushman & Wakefield