Validation Associate II

• Be involved in design of experiments, development of new methodologies and improving existing methodologies, data generation, report development and presentation
• Schedule, plan, communicate, and manage documents and follow-up on validation activities
• Interpret and apply regulatory requirements concerning validation activities
• Applies knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate
• Perform validation activities to lead and/or support cleaning, equipment, computer systems, utility, facility, and method validations
• Review and generate quality documents including validation protocols, SOPs, change controls, and non conformance event records as required
• Serves as a project lead for projects of intermediate scope with cross-functional teams
• Support regulatory inspections and responses as required
• Able to prioritize workload and tasks
• Ability to follow good project management practices to meet schedules while ensuring compliance with procedures and regulations

• BS Degree in Science, Engineering or Math with 2 or more years of experience
• Master's Degree with 1 or more years of experience
• At least 2 years of direct experience with writing and executing validation protocols is preferred
• Understand scientific strategies and be able to invent new methods or new avenues of investigation
• Good interpersonal/communication/influencing/negotiation skills
• Strong project management skills
• Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
• Proficient in Microsoft Word and Excel, computer software
• Some experience with statistical software helpful
• Direct or indirect industry knowledge
• Ability to work independently or in teams
• Physical demands of the position may require the ability to lift materials up to 20 lbs, dexterity to gown, mobility to maneuver around equipment, and enter into confined spaces
• Must not be allergic to Cephalosporins or Penicillin

Some experience with statistical software helpful

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• Medical and dental coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP)
• 401(k) Retirement Savings Plan (RSP)
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits