This is a direct-hire (permanent) salaried position with our client, and must work on-site in Philadelphia, PA 19112.

Overview

• The Senior Validation Engineer is responsible for supporting the qualification of the CGMP cell therapy manufacturing facility. This position is responsible for the development and execution of validation testing and documentation for a variety of equipment, utilities, components, products, and systems.
• Reporting to the Associate Director, Validation Engineering, the individual works internally across the organization to administer and continuously improve the site’s validation system. They will assist with the management of contract staff and project resources. They are required to act on problems of diverse and highly technical scope, requiring critical thinking and interaction with internal and external technical professionals. They ensure contract resources adhere to schedules and performance requirements in qualification of the new cell therapy facility and continuous validation. They exercise broad judgment within generally defined practices and policies and will exercise analytical decision-making abilities.
• Ensuring timely execution of all re-validation requirements through accurate requirements definition; authoring, executing, and summarizing commissioning and qualification protocols for GXP systems including equipment/test instruments, utilities, processes, and facility systems; assisting with the coordination of investigations, impact assessment, and resolution for validation and re-validation non-conformances; maintaining and reporting applicable department and system metrics; supporting capital project teams by defining and coordinating commissioning and qualification requirements; providing general technical advice on new equipment and modification to existing equipment to ensure that validation and qualification status is maintained in a state of control; and proactively identifying, assessing, and mitigating operational and organizational risks, and escalating key risks and issues

Essential Functions and Responsibilities

• Support for qualification and / or validation for systems and systems associated to iCTC cGMP capital projects
• Maintain periodic review of critical systems.
• Generate and execute validation protocols using Good Documentation Practices (GDPs)
• Investigate and resolve protocol exceptions or discrepancies
• Develop technical reports and validation summary reports
• Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.). Perform or facilitate design qualification
• Develop Standard Operating Procedures (SOPs), User Requirement Specifications, and other regulatory support documentation
• Perform risk assessments and impact assessments
• Assist with the Management validation contractor services during qualification of new facility and validation maintenance of critical systems.
• Expertise in FDA, PIC/S, and ICH qualification and validation requirements and creative risk- based approaches for meeting and exceeding the minimum requirements
• Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support the project
• Must adhere to company core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.

Travel

• Ability to travel 10%

Required Education, Skills, and Knowledge

• Bachelor’s degree in Life Sciences, Engineering or equivalent.
• 5-7 years of relevant operations experience for successful validation experience in the pharmaceutical or biotech industry including validation leadership positions on major cGMP capital projects.
• Demonstrable experience creating and utilizing systems for monitoring and controlling the execution of validation functions.
• Strong experience developing and executing validation protocols for Facilities, Utilities, Systems, Equipment, EMPQ, and Aseptic Process Validation in a CGMP environment
• Demonstrable experience maintaining validation policies, processes, and procedures for a new cGMP facility
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Must be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.

Physical Demands and Activities Required:

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
• Must be able to use near vision to view samples at close range
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

Mental :

• Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline

Work Environment:

• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.