Job Description
Software Validation Engineer – Medical Devices
Location: Boynton Beach, FL / Jacksonville, FL
Competencies: EIS : Medical Device & Regulations
Experience (Years): 4-6
Role Description:
CSV, SDLC, SQE, Analytical Instruments, LIMS, System Validation, QC Laboratories
Essential Skills:
- Software Quality Engineer/CSV EngineerA minimum of 4 years
- Working knowledge of software or system validation in regulated industry like Medical Device or Pharma
- Strong knowledge and experience of computerized system development life cycle (SDLC) approaches and validations strategies is required
- Experience with COTS/Custom made Analytical Instrument and experience working in QC Laboratories, R&D, manufacturing/operations is required.
- Software Quality Engineer (SQE)/ Computer System Validation (CSV) experience in Pharma/Medical Device is required.
- Good knowledge in areas of GxP is required including knowledge of CSV and data integrity regulations including but not limited to 21 CFR Part 11
- Experience in LIMS/CDS/ Analytical Instrumentation Validation is preferred and not mandatory
- Familiar or Experience in Quality Systems process development, support, integration, or enhancement is preferred.
- Software Quality Engineer certification (CSQE) or Certified Quality Engineer certification (CQE) is preferred not mandatory.
- Strong knowledge and experience of computerized system development life cycle approaches and validations strategies is required
- Familiarity with bioanalytical work and workflows, instrument software, and computer systems validation in the bioanalytical space is preferred
- Excellent communication, social skills, networking skills, a high level of organizational ability, and attention to detail is required
- Good interpersonal skills and Communication with the system administrator, system owner, and lab manager to plan, coordinate, implement and validation.
- Working knowledge of GAMP5 and SDLC is preferred A minimum of 4 years of experience in a regulated environment is required
Desirable Skills:
- Lead computer software validation (CSV) project planning activities including the creation or updates to URS, SDS and RTM documents.
- Create, review, and approve software validation documentation.
- Create and execute qualification protocols and document reports, review and approve software test scripts and code reviews.
- Review and approve internal and vendor software packages and test documentation.
- Prioritize and plan all assigned projects for the software validation department.
- Implement new or changed programs/policies/procedures related to CSV and support SDLC & software validation policies, procedures, and processes for computerized systems.
- Facilitate change validation as part of the Change Control Board (CCB) as the SQE representative.
- Support CSV improvement initiatives in Analytical Instrumentation Validation
- Identify and resolve barriers that impede business needs.
- Support compliance activities by participating in audit readiness, support internal and external audits pertaining to CSV.
- Serve as the Subject Matter Expert for CSV and manage investigations, responses, and remediation of site-specific CSV audit observations
- Must have very good written and verbal communication skills.
- Customer support experience preferred.
- Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required.
- Must be able to effectively prioritize and manage multiple activities and responsibilities.
- Ability to function in a team environment and deliver on team objectives is required.
- Ability to make decisions and solve problems while exhibiting situational judgement. Bachelor’s Degree is required, preferably in Engineering, Computer Science or a related technical field
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