Senior Validation Engineer - Automated Systems, Inc.

Senior Validation Engineer

12+ month contract role – strong potential for extensions

Onsite – Greater Chicagoland Area

Sponsorship is not available for this role now or in the future

Automated Systems, Inc. is actively recruiting for a Senior Validation Engineer for one of our global Pharmaceutical Manufacturing clients located in the Greater Chicagoland Area. In this job role, you will perform an array of validation activities in support of cGMP pharmaceutical manufacturing and will assist with internal project teams on validation/qualification initiatives. Other responsibilities in this role, will include dispensing suites; new compounding suites with multiple new mixing tanks and clean-in-place skids; new intravenous bag printing and filling suites and bag printers and fillers; new vial filler and related compounding, parts washing, autoclave, compounding rooms’ new water for injection generation systems and distribution loops; new clean steam systems; new air handling units and water chillers and new cold storage warehouse, etc.

Job Role Responsibilities

• Author validation plans; assist with the development of specifications for user requirements, functional requirements, and design requirements, trace matrices, validation summary reports and test protocols for installation, operation, performance of equipment, functional requirements, risk assessments, and IQ/OQ/PQ.
  
  
• Review commissioning, qualification and validation related system lifecycle documentation (user requirements, functional and design specifications, commissioning and qualification protocols).
  
  
• Assist with direction on equipment/process change control development (equipment, utilities, facilities, and processes) used to develop and manufacture products in a cGMP environment.
  
  
• Work closely with other validation department personnel as well as cross-functionally with Manufacturing, Engineering, Critical Utilities, Quality Assurance, and project management to achieve all project deliverables.
  
  
• Assist management with mentoring and training of colleagues on policies and procedures including the requirements for validation.
  
  
• Validation representative on validation projects leading by example on projects.
  
  
• Develop and recommend science-based solutions with a focus on continuous improvement and compliance.
  
  
• Perform risk assessment and mitigation steps to achieve attainment and maintenance of a validated state of compliance for all equipment, utilities, processes, materials, and facilities.
  
  
• Coordinate and execute validation protocol activities with consistent and effective communication with affected departments; working autonomously while keeping manager regularly updated.
  
  
• Work in a highly independent fashion, with minimal to no direction in the execution of duties, while keeping teammates and manager informed and providing guidance to other engineers as needed.
  
  
• Write protocols and technical study approaches.
  
  
• Review document changes for validation and deviation impact.
  
  
• Propose corrective actions to validation manager and appropriate departments to implement the required changes.
  
  

Experience, Education & Skill Requirements

• Bachelor's degree in engineering or related scientific discipline required with a minimum of 4 years of pharmaceutical industry experience or combination of work experience in Validation, QA, MFG, or Engineering.
• Combination of equipment qualification, process validation, or cleaning validation is acceptable; QA pharmaceutical experience also preferred.
• Validation experience with the following is highly preferred: Thermal characterization, Vacuum physics, Heat and mass transfer, Formulation, Aseptic Filling and Lyophilization.
• Experience in multiple regulatory inspections and knowledgeable in current industry standards and regulatory trends as they pertain to Validation of pharmaceutical or bio-pharmaceutical processes.
• Experience with completing Risk Assessments
• Experience in pharmaceutical or bio-pharmaceutical environments.
• Previous relevant experience with Change control requests and writing Validation plans.
• Previous experience in commissioning new or modified facilities, SCADA systems and air handling units
• Experience with Allerton or Lighthouse environmental monitoring control systems, preferred
• Previous experience with Standard operating procedure for set-up, operation and cleaning
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EMA) for validation of GMP facilities.
• Possess strong knowledge of commissioning, qualification validation, practices, including applicable regulations.
• Excellent technical writing, verbal communication and presentation skills.
• Proficiency in Microsoft Office, including Word, Excel, Power Point, Project.

Qualities

• Organized individual who is accustomed to working in a result oriented-focused, dynamic CMO environment.

• Professional and collaborative team player must have strong interpersonal skills.

• Honesty, integrity, respect and courtesy with all colleagues.

• Ability to inspire others to strive for excellence.

• Self-motivated and able to meet goals with minimal supervision.