Validation Engineer

A Pharmaceutical Manufacturing Company in Canton, Massachusetts is looking for a Validation Engineer to perform validations/revalidations according to FDA regulations and guidelines by performing the following duties: ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Performs validations and revalidations on equipment and processes, such as autoclaves, ovens, aseptic processes, product assembly lines, filling machines, sterilization processes and cleaning processes across multi-department personnel. Operates department and facility equipment according to defined procedures. Collects samples and delivers to appropriate laboratory area/personnel. Prepares necessary materials and appropriate documentation, and compiles final report packages. Analyzes and reports problems associated with equipment and processes. Compiles test results, comparing to established standards. Actively participates in department trainings and training of individuals, and contributes as a team to achieve department goals. Adequately summarizes systems, processes and equipment validated/revalidated and testing results. Designs scope of validation testing and acceptance criteria based on the proposed routine procedures in order to implement suitable and validated in-process controls. Maintains and organizes an assigned department responsibility (when applicable). EDUCATION and/or EXPERIENCE: Bachelor degree from a four-year college or university is required, or equivalent combination of education and experience. PHYSICAL DEMANDS: While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel objects, tools or controls and talk or hear. The employee is occasionally required to stand, walk, sit and reach with hands and arms. The employee must frequently life and/or move up to 25 pounds. Specific vision abilities required by this job include the ability to adjust focus. WORK ENVIRONMENT: While performing the duties of this job, the employee occasionally works near moving mechanical parts and is occasionally exposed to wet and/or humid conditions, fumes or airborne particles, toxic or caustic chemicals, extreme cold and extreme heat. The noise level in the work environment is usually moderate. Work in hot and humid environments at times. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Sunshine Act Armstrong reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Armstrong to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Armstrong intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Armstrong that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. EEO & Employment Eligibility Armstrong 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. Armstrong 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. Armstrong is an E-Verify employer. Armstrong is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Job Type: Full-time Pay: $31.25 - $40.87 per hour Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Schedule: Monday to Friday Weekends as needed Education: Bachelor's (Preferred) Work Location: In person