Software Validation Engineer

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