Validation Engineer

Description / Scope / Mission

The purpose of the Validation Engineer is to identify, design, execute, and maintain the validation lifecycle of all applicable manufacturing processes associated with the production of a drug item, to ensure said processes are capable of consistently delivering quality products. In addition, the Validation Engineer is to help ensure all products produced by Northern Labs are in line with and meet customer expectations and regulatory requirements (FDA cGMP, BRCGS Consumer Products standard, & ISO9001 standard).

Key Responsibilities/ Accountabilities

New Product Introduction:

Identify potential processes that will require validation prior to new product inception/implementation.

Identify potential failure modes during manufacturing by preparing comprehensive Failure Mode Effects Analyses (FMEAs).

Write Protocols for Installation Qualification, Operational Qualification, and Performance Qualification. Work with contract customers (where applicable) and/or internal departments as a cross functional team to create peer reviewed protocols prior to execution.

Support (where necessary) the execution of IQ, OQ, and PQ Protocols with various internal departments.

Compile required data and supporting documentation from execution of the Protocol; analyze applicable data and write the final Report, to provide objective evidence that the process is capable of consistent output, and therefore approved for “routine production”. 

Create/implement effective control plans.

Create/implement Master Validation Plans (MVPs).

Responsible for generating controlled documents to ensure the manufacturing processes are being followed within established validation parameters, and subsequently producing product that meets customer and regulatory requirements. 

Process various Quality Management System (QMS) documents as they pertain to validated processes/products, including Non-Conformance (NC) Reports, Corrective and Preventive Actions (CPAs), Deviations, Waiver.

Use Root Cause Analysis to identify the true root cause of NC product or processes. Based on the root cause, work as a team with various departments to create an action plan to prevent reoccurrence.

Work with contract customers for approvals of NCs, CPAs, Deviations/Waivers when necessary.

Existing Products

Conduct assigned sections of Annual Product Reviews (APRs) of regulated/drug products.

Conduct Document Reviews to ensure the document accurately reflects the actual process, the processes are actually being followed, and the process is within the established validation parameters.

See 1g, above.

Recommend and document changes to validated processes through Management of Change (MOC), responsible for the Origination and Rationale of the proposed change prior to submission for approval. Once approved, update controlled documents for manufacturing.

Effectively manage the continuous validation lifecycle of a product/process by conducting reviews for re-validation and updating the associated Master Validation Plan (MVP).

Provide support for external audits; process audit findings as requested by management.

Act as a liaison and knowledge reference between Quality and various departments (i.e., Blending, Filling), to ensure procedures are followed within the validated parameters, to ensure product is produced right first time.

MARGINAL JOB DUTIES:

Work with customers to resolve discrepancies in specifications, processes, etc. to ensure both parties agree.

Identify critical control points (CCPs), calculate control limits, and implement effective sampling plans for routine production. Review/update as needed.

Perform other duties as required or requested by management.

Education / Certification / Qualifications / Experience

• Background in manufacturing, with cGMP and FDA compliance preferred
• Proficient in Microsoft Word, Excel, and Outlook
• Excellent technical writing skills.
• Proficient in Microsoft Word, Excel, and Outlook; Minitab experience preferred.
• Minimum of one year experience involved in the manufacturing of drug products (cGMPs).
• Minimum of one year experience assisting with process validations.
  
  

LICENSE OR CERTIFICATION REQUIRED:

• Lean Manufacturing and/or Six Sigma Green Belt preferred
  
  

 

Specific Knowledge: (Technical/Product, Organizational and Interpersonal)

• Stand 10% of the time.

• Walk 10% of the time.
• Sit 80% of the time.
• Use hands to finger, handle or touch 100% of the time.

• Reach above shoulders less than 10% of the time.

• Climb or balance less than 10% of the time.
• Talk or hear 70% of the time.
• Taste or smell up to 10% of the time.
• Lift up to 25 pounds up to 5% of the time
• Close Vision (clear vision at 20 inches or less)
• Color Vision (ability to identify and distinguish colors)
• Ability to Adjust Focus (ability to adjust the eye to bring an object into sharp focus)
  
  

TOOLS/EQUIPMENT USED:

• Use the Computer up to 85% of the time.
• Use the Copier less than 5% of the time.
• Use the Telephone up to 10% of the time.

• Use Lab Equipment up to 5% of the time.
  
  

WORK ENVIRONMENT/PPE REQUIRED:

• Work near moving mechanical parts less than 5% of the time.

• Work in high, precarious places less than 5% of the time.

• Exposed to fumes or airborne particles up to 10% of the time.

• Risk of electrical shock less than 5% of the time.

• Work/job related travel less than 5% of the time.

• Moderate Noise