The successful candidate will maintain, execute, and support all validation projects and activities in accordance with Current Good Manufacturing Practices (cGMP). Maintain effective communication and has ability to work in a cross functional team. Adhere to cGMP and quality requirements in an FDA-regulated environment along with knowledge of 21 CFR Part 11. This position will report into the Senior Manager, Validation Engineering.
Validation Engineer will perform and lead system validation projects related to authoring and executing specifications and validation documentation for equipment/systems, instruments/equipment and systems according to cGxP and FDA 21 CFR Parts 11, 210 and 211.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Performs and leads system validation projects related to authoring and executing specifications and validation documentation for equipment/systems, instruments/equipment and systems according to cGxP and FDA 21 CFR Parts 11, 210 and 211. Typical deliverables to manage and execute are System Validation Plan, User Requirement Specification (URS), Risk Assessment, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM) and Periodic Review of Systems.
- Generate a validation plan detailing the scope of work and intent.
- Identify specific tests and requirements to be met in the IQ/OQ/PQ that address requirements.
- Ensure all work is in line with the site Validation Master Plan (VMP), regulations, procedures and practices.
- Review and execute Validation protocols to ensure compliance and adherence with applicable guidelines
- Write risks assessments and applicable test scripts according to cGMP and 21 CFR Part 11 compliance guidelines and the Validation Master Plan.
- Prepare validation summary reports for executed protocols.
- Liaise with various business function within organization in execution of the Validation program.
- Communicate validation approaches and requirements during planning/audits as needed.
- Write or revise relevant SOPs and cGxP documents to support validation activities.
- Facilitate continuous improvement of practices, documentation, forms, SOPs, and systems within the department.
- Maintains a thorough knowledge of the organization, policies, and Standard Operating Procedures (SOPs), adheres to all organizational standards defined in SOPs and company policies.
- Work with equipment/system owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures.
- Track and resolve deviations/exceptions during validation activities.
- Prioritize qualification activities in line with the project schedules and timelines.
- Co-ordinate validation/qualification activities with key stakeholders.
- Serve as the Subject Matter Expert (SME) and maintain knowledge and information in the validation area of expertise.
- Maintain team-working principles within the department and cross-functionally, promoting cooperation and communication working as a strategic partner with all other departments within the company.
- Manage Validation contractors to complete on-site validation if required.
- Follows company's safety policies, practices, and procedures in order to maintain a safe work environment.
- Other tasks as assigned by the manager.
ADDITIONAL POSITION REQUIREMENTS
- Exceptional written and verbal communication skills with superior organizational skills.
- Excellent problem-solving skills and the ability to analyze critical issues and develop assessments for risk and impact quickly and effectively.
- Ability to utilize Project Management methodologies to manage validation projects.
- Ability to work in a high pressure, fast-paced, environment.
- Ability to work with various scientists and management across various departmental groups to achieve company's goals and objectives.
- Ability to work independently and manage time with respect to project priorities.
- Have thorough understanding of the Bioanalytical Process.
- Ability to operate instrumentation within the limits required for validation development and execution, with the appropriate training provided by company staff or the vendor if required.
- Advanced knowledge and experience of complete MS Office system.
- Firm understanding of all associated technology platforms as needed for validation projects.
- Effective oral and written communication skills
- Effective interpersonal skills
- Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint
- Ability to work under pressure on multiple projects and deadlines
- Ability to effectively prioritize workload and manage changes in direction
- Ability to work in a team environment
- Familiarity with and adherence to regulatory guidelines consistent with company requirements
Host and manage vendor/ service representatives, as assigned.
QUALIFICATIONS: EDUCATION and/or EXPERIENCE
- Bachelors or Masters in a scientific field, preferably Chemistry or Engineering.
- At least three (3) to four (4) years of validation experience working in a regulated, cGxP environment.
- Extensive, in-depth knowledge and understanding of cGMP and quality requirements in an FDA-regulated environment along with knowledge of 21 CFR Part 11.
- Experience with the following applications/systems is preferred: LIMS, Empower and other typical GMP regulated systems.
- Experience with Electronic Data Management Systems.
- Read and interpret documents such as standard operating procedures, manuals, batch records, work instructions and specifications.
- Legible Handwriting
- Communicate clearly in writing and orally.
Apply concepts of basic arithmetic such as addition, subtraction, fractions, percentages, ratios and proportions to practical solutions.
OTHER SKILLS, ABILITIES OR QUALIFICATIONS
- Demonstrate effective collaboration and teamwork.
- Demonstrate experience working in a cGxP environment.
- Successfully completes regulatory and job training requirements.
- Work and be proficient with e-mail systems
- Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
- Ability to work with others in a team environment.