Validation Engineer III

Company: Meridian Medical Technologies
Location: Saint Louis
Posted on: March 19, 2023

Job Description:

ROLE SUMMARY

This position is for an individual contributor to the Quality Operations Validation department.

The successful candidate will assist in the development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols, perform testing and write validation reports. Generate validation protocols using templates. Responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manger.

ROLE RESPONSIBILITIES

• Assists with development of Aseptic product manufacturing equipment qualification/validation, Cleaning Validation & Process validation protocols, performs testing and write validation reports. Generate validation protocols using templates. Primary responsible for protocol execution of various types of basic processing equipment under the direction of Validation Manger.
• Issue data, memos and reports concerning above projects.
• Help to determine process capability of new equipment through execution of approved protocols and assures defined parameters are incorporated into respective operating procedures and batch records.
• Perform special projects as assigned by department manager.
• Adhere to all company and GMP procedures, along with safety regulations within the plant.
• Assist with validation activities performed by outside validation companies; assures that department and company policies are adhered to.
• Assist with the Site Change Management Program to keep all finished products, equipment, processes and facilities in compliance with contemporary industry standards and regulatory filings. EDUCATION & EXPERIENCE:
  
  At a minimum, the successful candidate must have a Bachelor's degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy or related science and 7+ years related experience and/or training, or equivalent combination of education and experience.
  
  PREFERRED QUALIFICATIONS
  • Knowledge of cGMP and internal SOPs and general knowledge of associated industry and regulatory guidance documents.
  • Sound working knowledge of the operation of various pharmaceutical processing equipment, labeling/packaging equipment and integrated inspection equipment.
  • Ability to read, analyze and interpret common scientific and technical journals; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; able to readily identify/report deviations to management in a timely manner.
  • To perform this job successfully, an individual should have working knowledge of Microsoft Office (Word, Excel, Outlook, Access, and Projects).
    
    Meridian Medical Technologies (MMT) is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. MMT also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
    
    MMT requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, MMT will consider requests for Reasonable Accommodations.

Keywords: Meridian Medical Technologies, St. Louis , Validation Engineer III, Engineering , Saint Louis, Missouri