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Validation Systems Engineer

2 months ago

Portsmouth, Virginia, United States Trinity Consultants Full time

Validation Systems Engineer

Location: Remote

Trinity Consultants is a leading engineering and consulting firm specializing in providing solutions to the pharmaceutical and biotechnology sectors. With a strong presence across various regions, our organization is engaged in a wide array of global projects related to facility design, process engineering, and quality assurance.

Our services encompass process validation, automation solutions, project management, facility/system design, and compliance consulting for prominent biotechnology and pharmaceutical manufacturers.

The ideal candidate will collaborate with a team of engineers focused on the design, automation, commissioning, and initiation of diverse processes, systems, and facilities. A blend of robust technical skills, automation expertise, and proficiency in technical documentation is essential.

Key Responsibilities:

  • Develop and implement Quality System documentation aimed at establishing effective validation practices within the organization.
  • Draft User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring compliance with Good Documentation Practices (GDP) and internal quality standards.
  • Design validation strategies supported by appropriate statistical analyses, coordinate validation activities, analyze results, and prepare validation reports.
  • Conduct Data Integrity Assessments and evaluate systems for compliance with relevant regulations.
  • Provide insights on user and functional requirements for current and future processing equipment, and create necessary documentation. Engage with manufacturers to ensure all relevant requirements are fulfilled.
  • Assist non-engineering personnel, including those from Research & Development and Manufacturing, to facilitate successful technology transfer and ongoing improvement.
  • Complete assigned tasks promptly and proactively communicate any delays or issues to the validation manager and other relevant stakeholders.
  • Review software specifications and design test protocols accordingly.
  • Adhere to all regulatory, corporate, and Quality System policies.

Qualifications:

  • Bachelor's or Master's degree in engineering or a related field.
  • A minimum of 4 years of experience in an FDA-regulated environment, with experience in both upstream and downstream equipment being highly desirable.
  • At least 2 years of experience working with DeltaV, capable of interacting with software and designing protocols for DeltaV customizations.
  • Experience in Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), and Quality Systems (Change Control, Non-Conformances, Requalification, etc.).
  • Strong understanding of the Computer Systems Validation lifecycle and documentation requirements.
  • Proficient in Microsoft Office Suite, including Word, Excel, and PowerPoint.
  • Ability to work independently with minimal supervision, manage multiple projects simultaneously, and demonstrate strong communication and teamwork skills.
  • Excellent technical writing and presentation abilities are essential.

**Please note, we are not able to work with any 3rd party vendors or C2C.**