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

After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play.

With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit .

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.