Validation Engineer / Specialist

Validation Engineer / Specialist

Position Type: Contract

Position Location: Birmingham, AL

Position Salary: $65/HR - $75/HR (Depending on Experience)

Responsibilities:

• Support and execute all phases of assigned projects from concept through implementation.

• Follow GMP regulatory compliance, adherence to the site Qualification & Validation Master Plan (QVMP), Standard Operating Procedures (SOP's) and Business Line Policies/Procedures.

• Work on multi-faceted projects (Capital, Client and Overhead), supporting multiple tasks/priorities of suitable complexity.

• Provide support to external departments for tasks that require qualification / validation expertise.

• Adhere to Plans, SOP's and Packages ensuring regulatory compliance (FDA/EU) with industry standards, practices and trends.

• Prepare Qualification / Validation Packages (Protocols and Summary Reports) within the assigned/specified area / project ensuring the results / conclusions are accurate and in compliance with Site Plans, Business Line Policies and Procedures

• Establishes safety as the number one priority through training, actions, and behaviors.

• Adhere to the Company's safety, health and environmental policies, procedures, and directives.

• Strong problem-solving and critical thinking skills with demonstrated ability to execute technical programs to achieve established goals; strong organization skills to multiple tasks at differing levels of complexity

Requirements:

• Bachelor's degree preferably in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.

• 3+ years working in the Pharmaceutical Industry performing Qualifications / Validations for new or modified systems

• Strong understanding of Regulatory Guidance Framework FDA/EU, Industry Best Practices (GAMP), and cGMPs

• Knowledge / hands on experience in setup and operation of Kaye Validator systems.

• Knowledge/exposure to aseptic pharmaceutical manufacturing process / production / facilities is a plus

• Knowledge and experience in use of the Kaye validator AVS and Kaye ValProbe Systems for temperature mapping is a plus

• Experience with implementation and qualification of BAS or BMS Systems

• Experience with temperature mapping protocol development

• Knowledge of Aseptic techniques and cleanroom requirements

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