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 DOEs.

· Supports the delivery of system solutions by assuring validation activities are conducted in a compliant but cost effective manner.

· Works closely with other groups to ensure the total solution delivered to the customer meets/exceeds expectations.

· 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

· 10 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

· Virginia

· Full time

· Full Benefits

· 6 month engagement, with potential to extend

· Start ASAP