Consultant, SME, Validation Engineer

Summary

Our client, a growing medical device manufacturer, requires a SME validation engineer to join their team. This individual will perform process validations and qualifications of new/existing equipment and processes in a medical device environment. Focus on validations will be to document the processes and equipment to current regulatory standards and requirements.

Duties / Expectations of Role

• This individual will provide leadership and technical support to engineering team on all aspects of the manufacturing process controls.
• Communicates current and applicable good manufacturing practices (GMP) (e.g.: ISO13485 / 21 CFR Part 820 / CMDR) to business partners.
• Executes functions needed to support change control activities and document management requirements.
• Collaborates with business partners and peers to define validation and change control activity requirements for individual projects.
• Establishes and communicates requirements for validation execution and documentation through daily interactions, training, and so on.
• Assists and supports the development of equipment and process validations by participating in the design of feasibility studies that assess manufacturing capability/reliability.
• Leads / participates in the preparation of risk assessments using tools such as Process/Design Failure Mode and Effects Analysis (PFMEA /DFMEA).
• Writes/revises or reviews /approves a variety of validation lifecycle documents.
• Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), sterilization, process validation, cleaning validations, packaging validation, distribution validations, requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports.
• Supports the delivery of system solutions by assuring validation activities are conducted in a compliant but cost effective manner.
• Performs investigations and troubleshoots validation problems for equipment, performance process and system and so on.
• Audits the compliance of validation activities and assists during internal / external audits. Handles complex technical issues for manufacturing processes that are to be transferred to satellite facilities.
• Proactively identifies and resolves issues, and escalates concerns as appropriate.
• Ensures corrective actions are completed in a timely manner.
• Promotes continuous improvement by ensuring adherence to quality principles.
• Seeks out and actively participates in business initiatives that contribute to service excellence. Collaborates and teams with Laboratory, Quality and Validation Engineering, LIMS, and project management personnel.

Mandatory Requirements

• Experience in Quality, Regulatory and/or Compliance within medical device
• 20 years of experience in validation (and statistical tools such as Sampling Plans, Experimental Design and Optimization) is required.
• Knowledge of current and applicable GMP regulations is required.
• Experience with collagen products
• Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations is required.

Nice to Have Requirements

• Knowledge or experience with quality audits is preferred.
• Experience with Six Sigma/Process Excellence tools, training, and/or certification is preferred.
• ASQ Certification or equivalent is preferred but not mandatory

Term & Start

• Onsite in Virginia
• Full Benefits
• 6 month engagement, with potential to extend
• Start ASAP