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Job Description
Position Details:
Client:
Medical Devices Company Position Title:
Validation Engineer Duration:
06 months (Possible extension)
Location:
San Diego, CA 92121 (Onsite)
Pay Range:
$30/hr to $35/hr
Job Description:
Client is looking for an outstanding Validation Engineer-Contractor who will effectively lead quality related validation activities to support the Quality Management System. The end goal is to deliver consistent and high-quality validation and supporting documentation for design and development organization. This role requires strong technical, communication, interpersonal and organizational skills, and a solid understanding of the application of
FDA, ISO 13485, ISO 14971
standards and company strategies.
Requirements:
Technical Writing Write procedures, investigations, protocols, deviations, CAPA's, reports, change controls, etc. to support ARDx Towne Centre site departments. Perform and document investigations related to validation activities and performs risk assessments of equipment, processes and systems to determine the scope of validation efforts. Generates validation documentation as required (URS, FRS, DRS, FAT, DQ, engineering studies, IOQ, PQ, PV) for cleaning, shipping, sterilization, facilities, utilities, systems, equipment qualification/requalification, computer system validation, spreadsheets, test method validation and process validation. Writes and/or revises
IQ, OQ, PQ
related documents, including any or all of the following: SOP's, validation master plans, guidelines and execution plans, automation test plans and technical documents. Responsible for writing Standard Operating Procedures related to Validations and responsible for training Quality Assurance and R D personal in the validation processes. Service Delivery Performs on site or support work, including but not limited to: Validation protocol executions for
FAT/SAT/IQ/OQ/PQ/PV.
Equipment Qualification test execution. Investigations and deviations. Provides gap analysis, risk management, risk assessment, risk analysis and validation strategy. Data integrity assessments and review of client data Executes protocols and resolves deviations/discrepancies, analyzes data and writes reports. Performing and supervising thermal mapping of temperature-controlled units, Laboratories, warehouses, etc. Ensures that validations are documented using Good Documentation Practices and are in compliance to
FDA, ISO
13485, and Client's Policies and Procedures. Evaluate impact on legacy qualifications/validations and determines the scope of re-validation. Support the continuous improvement to the Quality Management System, with a specialty focus on validation processes. Responsible for maintaining a Site Master Validation Plan and ensuring that critical Performance Qualification and/or Process Validations are performed per established schedule. Identify and propose remediation for existing and potential validation issues; provide technical expertise and provide solutions to maintain compliance. Assist with internal and external audits. Manages validation metrics. Manages change control for validation deliverables in the electronic documentation management system. Participate in multiple, concurrent projects. Develops timelines and tracks project status on assigned projects. Keeps stakeholders informed on the status of important projects. Performs other duties as assigned by Management.
Basic Qualification:
Bachelors' degree (B.S.) in a Science related field (Engineering, Biology, Chemistry or equivalent) 5+ years of related work experience in a medical device industry with strong technical competency in performing equipment qualification (IQ/OQ/PQ), facility/lab qualification, process validations and excel spreadsheet validations. Proficient understanding of Design Control, Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP) Significant experience with application of the FDA regulations and recognized standards (e.g., FDA 21 CFR 820.30, FDA 21 CFR 820.70, FDA 21 CFR Part 11, ISO 13485, ISO 14971, cybersecurity)
Preferred Qualifications:
Experience in validation of In Vitro Diagnostic Lab equipment (e.g., Real- Time PCR System, Freezers, Refrigerators, Environmental Chambers, Incubators) and Thermal Mapping, Computerized System Validation. Experience supporting
ISO 13485
inspections and FDA inspections. Experience in a multi-site development environment. Experience in compliance management within a rapid-growth, dynamic organization. Statistical or Lean Six Sigma background Working experience with GAMP5 and FDA's Computer Software Assurance initiatives Working experience with Agile, Maximo and ViewLinc.
Competencies:
Good working knowledge of Excel and MS Word software Working knowledge of quality techniques such as root cause analysis, 5 why's, and Ishikawa diagrams. Excellent problem solving and decision-making skills. Self-starting, detail oriented, and ability to focus on task at hand Initiative to work towards goals with minimal supervision Ability to work independently with multiple departments to resolve Validation issues Must be able to work effectively in a fast paced, cross-functional team-oriented environment Well-developed English written and verbal communication skills
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, longterm disability insurance, shortterm disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually AS Applicable)
