Jobs

Description

Onsite

Extension possible

First shift. Start time 7:00 am - 9:00 am

MUST HAVE Validation experience and Quality experience.

What would immediately turn you off from a candidate upon resume review?

• No relevant experience. (equipment is only freezers, fridge and chambers)

Has never authored a validation

• Has never authored risk assessments ( pFMEA , NCE, experience)  

Schedule & Expectations

• Typical schedule:8-4 or 9-5
• Shift start time: flexible. Must be in by 9:30
• Shift end time: flexible (dependent ton time in)

Skills & Experience

Top 3 required skills (ranked):

• Authoring Validation and strategies
• Review of change control ( good GMP knowledge)
• Detail oriented

Soft Skills & Work Style

• Important soft skills: communication with cross functional teams and escalation with management
• Preferred work style (independent, team-based, fast-paced, etc.): fast paced, independent work.

Skillset Matrix Manager Notes

• Quality Reviews and assessment of Non conformances, Change orders. Review and approve development studies. Attend project meetings and draft Validation protocols & reports, assist in execution.
• Preferred background/prior work experience? Validation experience in custom equipment. Design validation protocols and statistical sampling.
• Risk assessment in FMEA format
• Priority soft skills Good at problem solving.
• Working cross functionally with other departments.
• Organized- able to manage multiple projects and tasks
• Communication- keeping every department in the project aware of the project needs.

Job Summary

• The Quality Engineer is responsible for validation of analytical methods, cleaning, production process, equipment qualification, facilities/utilities qualification, and raw materials qualification.
• Additionally, generate and maintain process FMEA for production processes, perform risk assessments for process related non-conformances and planned deviations, provide support and content for regulatory submissions, write master validation plans, protocols and reports, support equipment and facilities change controls, and perform validation impact assessment for change orders.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Provides Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development.
• Author master validation plans and reports.
• Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning).

Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities).

• Determine validation strategy based on acceptable risk-based approach.
• Lead cross-functional team to write PFMEAs under limited supervision.
• Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).
• Assist in maintaining validation records.
• Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.
• Review regulatory submissions and/or notifications under limited supervision.
• Propose improvement projects with supporting data, flowcharts, etc.

 

Physical Demands

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Lifting/moving and carrying products weighing up to 40 pounds.
• Exposure to moving mechanical parts, vibration and/or moderate noise levels.
• Exposure to hazardous chemicals or other materials.
• Exposure to blood.

Qualifications

Education

• Bachelor’s degree in Science or Engineering.

Experience

• 0-2 years of experience in a diagnostic, medical device, biotech or pharmaceutical company.

Skills

• Proficient in validation methods and evaluation criteria.
• Experience with process validation, analytical method validation, cleaning validation, facility/utility and equipment qualifications.
• Experience with risk analysis and PFMEA.
• Working knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971).
• Working knowledge of 21 CFR Part 11.