Position SummaryThe Validation Engineer II is responsible for the design, scheduling, execution, and evaluation of scientifically and statistically sound qualification and validation studies. This role demonstrates that critical cleaning, controls, equipment, facilities, processes, and utilities function consistently and repeatably in compliance with regulatory requirements, product license restrictions, and policies affecting final product integrity.
The Validation Engineer II prepares concise technical documentation, provides validation support to Business Development, Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs, and may lead or provide validation oversight for small- to medium-sized project initiatives.
Key Responsibilities- Serve as a validation representative and, when assigned, Validation Project Manager on cross-functional project teams.
- Research applicable governmental and regulatory requirements for assigned projects and ensure study subjects meet required specifications.
- Prepare scientifically sound validation study protocols incorporating defined specifications, acceptance criteria, and assessment procedures.
- Schedule and coordinate validation study execution with the appropriate departments.
- Provide validation oversight for small- and medium-sized project initiatives.
- Prepare detailed documentation dossiers summarizing experimental results, specifications, and conformance to defined acceptance criteria.
- Develop and execute complex procedures and methods with a high level of quality.
- Prepare test plans as required by Equipment Change Orders.
- Maintain close communication with Business Development, Engineering, and Manufacturing regarding validation challenges and opportunities.
- Provide technical support to Business Development, Engineering, Manufacturing, Quality Assurance, Quality Control, and Regulatory Affairs as needed.
- Assist with development of validation policies, programs, SOPs, and quality standards that meet industry, quality, and external regulatory requirements.
- Support the facility during internal and external inspections.
- Work directly with management, contract customers, and contract engineers.
- Maintain the effectiveness of Quality System components relevant to the position.
- Identify, evaluate, and manage risk to ensure product quality.
- Perform other duties as assigned.
QualificationsEducation- Bachelor of Science degree in Engineering or a related science discipline preferred.
Experience- Bachelor's degree in Engineering or a closely related physical science with at least three years of directly related experience, or an equivalent combination of education, experience, and training.
- A master's degree with at least two years of related experience may be considered.
- Knowledge of current Good Manufacturing Practices (cGMPs), direct pharmaceutical manufacturing methods, and validation principles.
Knowledge & Skills- Ability to interpret written, oral, diagram, and schedule-based instructions.
- Ability to work independently on multiple projects and meet deadlines with limited supervision.
- Strong documentation, problem-solving, analytical, and mechanical aptitude.
- Detail-oriented with demonstrated initiative, sound judgment, ethical decision-making, and investigative ability.
- Strong verbal, written, and interpersonal communication skills.
- Ability to interact effectively with individuals and personalities across departments.
- Proficiency with business computer applications, including word processing, spreadsheets, and database software.
- Familiarity with cGMP and safe work practices.
- Ability to read, write, and speak clear English.
Physical Requirements & Work Environment- Frequent sitting, standing, walking, reading written documents, using a computer monitor, reaching, talking, writing, and listening.
- Occasional bending, grasping, carrying, stooping, kneeling, and crouching.
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds.
- Fast-paced, performance-driven, customer-focused, collaborative, and inclusive work environment.
