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Computer System Validation Engineer

Blue Ash, Ohio
General Purpose of Position:
This position performs and leads computer system validation (CSV) projects including developing, authoring, and executing CSV documentation and SOPs according to ISPE GAMP 5 Validation Life Cycle. The position is responsible for the execution, tracking, and reporting on validation and qualification projects. The role partners cross-functionally at the site to create, administer, and improve computerized system validation deliverables to maintain data integrity, supporting ALCOA+ principles throughout the CSV lifecycle.

Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Plan, coordinate, and execute computer system validation projects according to Aprecia policies and procedures, as well as regulatory requirements.
2 Perform risk assessments and ensure appropriate test plan development, test execution, data analysis, and report writing.
3 Collaborate to develop, maintain, and improve validation master plans, CSV protocols, reports, risk assessments, gap analyses, traceability matrices, SOPs, and other validation documents for the Aprecia site.
4 Perform testing of computerized systems, such as laboratory information management systems (LIMS), manufacturing execution systems (MES), enterprise resource planning (ERP), building automation systems (BAS), and electronic batch records (EBR) using manual or automated methods.
5 Review and approve validation deliverables from vendors or contractors. Author cover/gap protocols for vendor supplied Commissioning & Qualification documents and provide oversight for vendor executed test scripts.
6 Use risk analysis to ensure appropriate parameters are evaluated with the required statistical approach to associated testing for justification and support of critical process parameters and quality attributes.
7 Monitor and audit the performance, compliance, and data integrity of the computerized systems on a periodic basis. Assess the need to update or requalify/revalidate systems as necessary, due to changes or upgrades.
8 Lead projects in cross-functional teams to ensure the overall success of a Validation & Qualification projects. Work with Validation management to provide cross-functional leadership to ensure project goals are met.
9 Work with internal stakeholders and vendors to plan for validation activities for new equipment and software upgrades including review of vendor supplied protocols, design specifications, configuration specifications, and qualification documents.
10 Help communicate Computer System Validation approaches and requirements during audits and inspections.
11 Other duties as required.

Reporting to this Position: 
No direct reports.

Travel:  
Position may require up to 10% travel.

Work Shift: 
This position works days.

Knowledge, Skills and Abilities:
  • Superior project management skills
  • Strong oral and written communication skills across diverse levels of the organization
  • Strong organization, relationship-building, and leadership skills
  • Ability to work independently or as part of a cross-functional team under deadlines and changing priorities
  • Strong problem-solving, critical thinking, and math skills
  • Ability to perform long-range planning in a team environment 
  • Ability to collaborate and negotiate successfully in a team environment
  • Willingness to work extended hours to complete job responsibilities
  • Expert working knowledge of Microsoft Office, Microsoft Project, and related computer programs required

Education and Experience:
  • Minimum Bachelor’s degree in Engineering, Science, Math, or Computer Science, or related discipline. Master’s degree is a plus.
  • Minimum 5 years of experience in computer system validation in the pharmaceutical or biotechnology industry.
  • Excellent knowledge of current good manufacturing practices (cGMP) and good automated manufacturing practices (GAMP). Familiar with 21CFR and Annex 11.
  • Experience with various computerized systems such as LIMS, MES, ERP, EBR and their validation tools and methodologies.
  • Proficient in writing clear, concise, and accurate validation documents (e.g., URS/FS, Trace Matrices).
  • Strong risk analysis, problem-solving, and troubleshooting skills.
  • Proficient knowledge of ALCOA+ and Data Integrity principles.
  • Working knowledge of the manufacturing, packaging, laboratory, and quality systems/processes needed to develop and produce OSD pharmaceutical products required.

Physical Demands and Work Environment: 
  • Ability to sit for extended periods to perform job responsibilities at a desk or meeting table.
  • Good manual dexterity to operate computer, keyboard, and general office equipment.
  • Good eyesight to read technical/instructional materials and electronic communications.
  • Good hearing to address questions during presentations, to facilitate team discussion, etc.
  • Occasional odd body positions (reaching, twisting, bending) in the performance of job duties.
  • Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (i.e. respirators, over-gowning, gloves, steel toe shoes).
 
GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.
 

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