Manufacturing Validation Associate II

• Execute manufacturing equipment qualification activities (IQ/OQ/PQ) for new and existing production equipment
• Support process validation and continued process verification (PPQ/CPV) activities in a GMP manufacturing environment
• Lead and support cleaning validation activities, including protocol execution and sampling activities
• Be involved in design of experiments (DOE), equipment/process troubleshooting, development of new approaches, and improvement of existing manufacturing methodologies
• Generate, analyze, and interpret manufacturing validation data, develop reports, and present results to cross‑functional teams
• Schedule, plan, communicate, and manage validation documentation and field execution activities performed onsite in manufacturing areas
• Interpret and apply regulatory requirements (FDA, cGMP) related to equipment, process, cleaning, utilities, and facility validation
• Apply working knowledge of cGMPs, SOPs, and site procedures to ensure compliant execution of validation activities
• Perform validation activities to lead and/or support equipment, process, cleaning, utilities, and facility validations
• Provide limited support for validation of manufacturing‑associated computerized or equipment‑integrated systems, as applicable to overall equipment or process validation
• Review and generate quality documents including validation protocols, SOPs, change controls, and nonconformance investigations
• Serve as a project lead for validation projects of intermediate scope, coordinating with Manufacturing, Engineering, Maintenance, Quality, and MSAT
• Support regulatory inspections and responses related to manufacturing validation activities
• Effectively prioritize workload and manage multiple validation activities while maintaining compliance with procedures and schedules

• BS Degree in Science, Engineering or Math with 2 or more years of experience. Master's Degree with 1 or more years of experience
• 2 years of direct, hands‑on experience writing and executing equipment, process, or cleaning validation protocols in a GMP manufacturing environment
• Ability to work at least 5 days onsite in the plant
• Demonstrated experience with IQ/OQ/PQ, PPQ, or cleaning validation is strongly preferred
• Ability to understand scientific and engineering principles and apply them to manufacturing equipment and process validation challenges
• 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
• 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
• Time-off benefits such as 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