Principal Validation Engineer Computerized systems
Computer systems validation
Reports To (Position Title):
Associate Director, Validation
29 Jan 2016
26 Jun 2019
Brooklyn Park, MN, USA
OBJECTIVES: (Briefly summarise the overall purpose of the position. Objectives should
be written in 3 4 bulleted statements).
- Support the validation of plant automation and process control systems, along with QC laboratory and Desktop based business and analytical systems.
- Provide leadership in scheduling, planning and execution of validation projects for site based computer systems.
- Develop, complete, log and archive computer systems validation documentation.
ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 10 bulleted task statements should be identified).
- Define validation strategies and oversight through the implementation of validations plans for site based computer systems.
- Lead risk assessments to identify critical SDLC activities and deliverables during the implementation and validation of various computer systems.
- Lead and manage various validation activities and author/review related documents including validation plans, risk assessments, 21 CFR compliance assessments, qualification protocols, and summary reports.
- Lead qualification protocol execution, and manage protocol deviations investigation and corrective action activities
- Participate in user/system requirements gathering, design qualification, and CAPA investigations.
- Collaborate closely with supplier quality and system owners in defining the role of software suppliers. Assist in evaluation and oversight of supplier activities and documentation related to system qualification.
- Plan computer validation projects and track execution of validation activities versus project timeline. Manage and plan the work of the internal and contract resources.
- Perform change control assessments and write/review validation plans, qualification protocols and summary reports. Manage the execution of qualification protocols and review test results.
- May Supervise and/or mentor lower level validation engineers
- Support development of best demonstrated validation practices within the validation department, based on current industry practices and regulatory guidelines.
- Complete mandatory training within required timeframe
- Perform other duties as assigned
SCOPE OF SUPERVISION:
NUMBER SUPERVISED WORKERS
up to 2
Up to 4
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
- Bachelor s degree in Sciences/Engineering (other degrees accepted provided the individual has relevant experience
- 5-8 years of relevant experience within the pharmaceutical, biotechnology or biopharmaceutical industry preferred
- 2-3 years of experience in leading people and projects highly desirable
- Working knowledge of cGMP guidelines, FDA 21 CFR Part 11, 210/211, EU's Annex 11 guidelines and other international regulatory requirements preferred.
- Previous validation experience in Rockwell Automation, FTView SE, ControlLogix, FTBatch, SQL Databases and OSI Pi as well as lab equipment and software such as QC LIMS and Empower, building automation, and IT infrastructure preferred.
- Sound industry knowledge, project proficiency, and autonomy expected. Considered a validation Subject Matter Expert (SME) in one or more areas of plant automation and process control systems, QC Chemistry and microbiology systems, metrology business systems and IT infrastructure.
- Expertise in Software Development Life Cycle (SDLC), 21 CFR Part 11, EU's Annex 11, and GAMP 5 requirements desirable.
- Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
- Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
- Proficient in Microsoft Word and Excel, Project and other desktop computing software.
- Able to establish and manage multiple cross-functional teams simultaneously.
- Project management experience preferred
PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).
- In general, the position requires a combination of sedentary work and walking around the cGMP manufacturing facility.
- May be required to work off-shift hours to help support 24-7 operation
- May occasionally work in a clean room environment and wear special garments and personal protective equipment (e.g. hard hats, safety shoes, safety glasses, ear plugs) due to safety requirements in specific areas.
- May be required to travel - less than 15%
Brooklyn Park, MN