The Principal Validation Engineer position is an experienced level position in the Validation Department. The primary responsibilities are to develop and execute Process Validation protocols, IQ protocols, OQ protocols, PQ protocols, Commissioning plans, under the direction of the Validation lead Engineer. Assist to coordinate and execute the Process Validations, Cleaning Validations, IQ, OQ, PQ qualifications, and Commissioning plans.
What is expected of you for success in your role
Desired Skills & Experience
- Develops Process Validation protocols, IQ protocols, OQ protocols, PQ protocols and Commissioning plans with minimal direction from the Validation lead Engineer.
- Obtains required resources to support Validation and Qualification projects
- Executes approved Process Validation protocols with the support of Operations personnel with minimal direction from the Validation Lead Engineer.
- Executes approved IQ, OQ and PQ qualification protocols and directs contractors to support protocol execution with minimal direction from the Validation Lead Engineer.
- Leads a validation project in the development of Process Validation protocols, IQ protocols, OQ protocols, PQ protocols and Commissioning plans
- Interfaces with management to provide and obtain information and to build consensus regarding project direction.
- Coordinates and communicates with stakeholders to ensure accurate and timely completion of projects
- Prepares reports using data from Process Validation, In-process Manufacturing testing In-process QC testing, and Finished Product QC testing
- Prepare reports using Cleaning Validation data from QC testing
- Prepare reports using IQ, OQ, PQ, and Commissioning monitoring and test data
- Perform root cause identification of product related activities
- Work flexible hours to meet the demands of the business
- Writes project status reports for site Management
- Prepares validation project schedules
- Writes other reports and correspondence as required
- Reviews, amends, and writes applicable SOPs
- Assures cGMP and SOP compliance
- Ensures projects are on schedule
Competencies To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Expert with current Good Manufacturing Practices (cGMP’s)
Must possess a solid understanding of FDA validation and qualification guidelines
- Expert with pharmaceutical manufacturing equipment and facilities
Work in a safe manner
- Able to review Algebraic, Geometric and Statistical calculations for data analysis
- Able to use MS Word, MS Excel, MS Outlook, and MS Visio for report preparation, data analysis, and interoffice communication
- Strong oral/written communication skills
- Uses judgment, creativity, and sound technical knowledge to obtain and recommend solutions
- Demonstrated ability to prioritize, manage and schedule in a high throughput equipment environment to meet project and department objectives while maintaining quality goals
- Effective administration skills, including ability to write protocols and other technical documents
- Must have excellent interpersonal skills, be highly self-motivated, well organized, and be able to develop alternative solutions to complex issues
- Quality management – looks for ways to improve and promote quality and demonstrates accuracy and thoroughness
- Planning/organizing – prioritizes and plans work activities, uses time efficiently and develops realistic action plans
- Adaptability – adapts to changes in the work environment, manages competing demands and is able to deal with frequent change, delays or unexpected events
- Dependability – is consistently at work and on time, follows instructions, responds to management direction and solicits feedback to improve performance
- Safety and security – actively promotes and personally observes safety and security procedures, and uses equipment and materials properly
- Bachelor’s degree in science, engineering supplemented by at least four years’ work experience and/or validation in a Device and/or Pharmaceutical, cGMP environment.
- Previous experience in compliance and qualification/ validation is also required as is demonstrated technical proficiency with the manufacturing process.