Validation Engineer in Burlington, MA

Job Snapshot

Job Description

Description

Validation Engineer in Burlington, MA AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries.  The Validation Engineer is responsible for developing and executing validation and revalidation protocols for processes, equipment, utility, and test systems. This person will work with Engineering and Facilities personnel to assure proper installation and operation of systems prior to and post validation. This individual will provide technical support to users of validated systems as required. Will provide assistance to Senior Engineers in support of on-going projects, as well as perform Preventive Maintenance and Calibration tasks as required.
The Validation Engineer works under the direction of the Director or a designate; interacts with all other departments for Engineering and Validation-related issues as required.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. Responsibilities
• Develop and execute required protocols and complete reports for equipment, process utility, test, and software validations and revalidations as assigned
• Develop and write Standard Operating Procedures, protocols, incidents, and final reports for new processes and equipment, in conjunction with the system owners
• Support department projects by assisting senior engineers on ongoing projects
• Perform Preventive Maintenance and Calibration tasks as required following existing procedures
• Support internal and external audits by providing data appropriate to the investigation as required
• Keep Department Management and personnel aware of Engineering related issues that may have a regulatory compliance or financial impact

Requirements
• Bachelor’s Degree required; Chemical Engineering Degree preferred
• 1+ years of experience in Pharmaceutical industry
• Familiarity with validation tools and processes, including temperature mapping and use of Kaye Validator
• Familiarity with FDA and EU regulations for pharmaceuticals and medical devices
• Strong technical writing skills are required to author validation documentation
• Ability to work semi-independently; demonstrated ability to interact well with other technical departments
• Excellent communication skills
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear.
The employee frequently is required to reach with hands and arms.
The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl.
The employee must occasionally lift and/or move up to 50 pounds.
Specific vision abilities required by this job include close vision, and ability to adjust focus.
Work Environment
While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations).
The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and may be expected to work with electronic equipment (always being aware of one’s environment and taking proper precautions is required). The noise level in the work environment is usually moderate. Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials. 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. All interested applicants must apply online. AMRI is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. #LI-AC1

Qualifications

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Job: Quality
Primary Location: Burlington, MA
Schedule: Full time
Shift Type:

AMRI is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you'd like to view a copy of the company's affirmative action plan or policy statement, please email jobs@amriglobal.com. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email jobs@amriglobal.com. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.

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