Validation Specialist (BBBH10924) Manatí, Puerto Rico

Computer System Validation Specialist Job Description

PRINCIPAL OBJECTIVE OF POSITION
Performs computerized systems validation for the Company's manufacturing facility’s cGMP IT systems, manufacturing automated process control systems and equipment according to all Federal, International, State and Corporate Regulations. Responsible for the design, development and execution of software & computer validation protocols and computer validation plans, for the manufacturing operations. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

MAJOR DUTIES AND RESPONSIBILITIES
1. Works with the site’s IT Computer System Validation Personnel and the site’s QA/QC management in development and execution of Software/Computer Validation plans for automated equipment, processes, and systems.
2. Identifies computerized systems validation needs through in-house assessments.
3. Develops Software/Computer Validation Protocols according to BMS policies on computerized systems validation. .
4. Coordinates and executes activities as per approved Protocol.
5. Recommends acceptance of the computer software, as determined from the tests performed on the Protocol. Analyzes data in order to determine acceptability. Recommends actions to be taken if the software is not accepted.
6. Generates Final/Validation Report in accordance with actual FDA certification concepts.
7. Advises the IT Director on the adequacy/completeness of Software Operational Qualification Protocols for his/her approval.
8. Promotes and supports Plant’s Safety, cGMP and SOP programs.
9. Maintains close communications with Site plant projects to keep abreast of computerized system needs and impact on computer validation.
10. Performs computerized systems validation in conformance with cGMP's, plant procedures, corporate policies, and applicable regulations (FDA, DEA, etc.)

KNOWLEDGE/SKILLS

  • Bachelor Degree in Computer/Software, Industrial, Mechanical Engineering or Electrical Engineering.
  • Training in validation methodologies, technologies and process control computer systems.
  • Three (3) years of experience in computer systems.
  • Through knowledge of cGMP and FDA regulation is a must.
  • Excellent communication skills (oral, written and reading) in Spanish and English at all levels
  • Proven skills in projects management and validation of manufacturing and quality related systems.
  • Knowledge of manufacturing equipment and processes (e.g. Packaging, Tablet Press, etc.) a must.
  • Able to work under pressure
  • Willing to work irregular hours, rotative shifts, weekends and holidays, when necessary.

    Approx. Duration: 10 months


    About Hired By Matrix

    For more than 25 years, Hired by Matrix has been providing temporary and long-term contract staffing solutions to Fortune 1,000 as well as mid-market companies nationwide. Our clients include major pharmaceutical, delivery & logistic, business information, financial and entertainment companies. The technology that we support is as diverse as our clients. We provide consultants with experience in mainframe legacy technology all the way to cutting edge technologies, like web and mobile application development. Our consultants are in roles that include Project Managers, Architects, Business analysts, QA, developers and infrastructure & network specialists. At the request of our clients we have broadened our capabilities across a variety of different areas, including: finance and accounting, R&D, clinical sciences and administrative. And as a woman-owned, WBENC-certified business we’ve helped companies grow their Supplier Diversity spend which is certainly a nice added benefit as well.

    Our extended network of qualified contract professionals offers nationwide contracting capabilities.

    Our dedicated team of account managers and recruiters collaborates closely with each of our clients to understand their staffing needs, corporate requirements and company cultures before building robust, fully customized pipelines of highly-qualified contract professionals in response.