Title: Validation Engineer
Location: Malvern, PA
Schedule: 1^st shift Mon-Fri
Type: Direct
Start date: Immediate.

Our client is looking for Validation Engineer to work at a well-established Pharmaceutical CDMO in the Malvern, PA.

Responsibilities:
 

• Primary responsibilities include validation protocol execution (IQ, OQ, PQ & PV), data analysis and final report preparation for facility, utilities, equipment, instrumentation, process, and cleaning.
• Ensure that projects meet the requirements for design and installation of chemical and pharmaceutical production plants.
• Maintain effective communication and ensure alignment in coordination with appropriate teams.
• Support facility certification for new Manufacturing (process equipment & facility-support equipment) and Quality Control facilities as needed as well as the continued operation of such facilities.
• Manage all plant qualification and validation, by coordinating the various activities aimed at the production of the documentation to be approved by the relevant authorities (FDA, etc.).
• Ensures systems and processes are validated in a compliant manner in accordance with FDA and EU requirements.
• Actively participate on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
• Completes accurate and timely assessments associated with change control activities.
• Ensures change control activities for systems are completed in a manner in compliance with FDA and EU regulations.
• Support validation of new and existing equipment, processes and instrumentation as needed.
• Write and review protocols, summary reports and other documentation associated with validations.
• Coordinate Validation activities within our client's USA as well as with outside vendors as needed.
• Represent the Validation department on cross-functional teams (Manufacturing, Engineering, Technical Support and Quality groups).
• Assist in the training of and/or direct the efforts of less experienced Validation Engineers and Validation Technicians.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations, and industry codes.
• Operate in achieving high standards of General GMP Compliance;
   

•  Bachelor’s degree or equivalent experience in life sciences or engineering.
• A minimum of three (3) years validation experience in the pharmaceutical or biotechnology industry.
• Experience preparing protocols, executing data analysis, and report writing.
• Ability to demonstrate broad understanding of:
• Concepts of Validation
• Fundamental understanding of validated computer systems, equipment, analytical instrumentation, utilities, process, and cleaning – including training others.
• GMP compliance knowledge including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others.
• Change control processes.
• Root cause analysis techniques and cGMP documentation practices
• cGMP regulations, GMP and other industry standards pertaining to validation.
• Technical requirements for Validation and of biopharmaceutical equipment, facilities and/or instrumentation
• Excellent written and verbal communication skills a must.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.