SRG, the leader in the Life Sciences human capital industry, is looking for contract Validation Engineers located in Greater Boston, MA. There are multiple positions available.

OVERVIEW:

The Validation Engineer is responsible for Qualifying state-of-the-art GMP equipment. The Engineer will coordinate cross-departmentally and with suppliers for equipment controls and qualification required to establish and document the Suitability for the Intended Use (including review of dFMEA, pFMEA, URS, vendor manuals, etc.) Troubleshooting and testing of manufacturing instruments and equipment per the SOPs (Standard Operating Procedures). The Engineer will assist with evaluation of equipment failures and determine the need for re-qualification and ensure all actions are documented appropriately.

JOB RESPONSIBILITIES include, but are not limited to:

• Authorizing and reviewing equipment installation qualifications
• Authoring and/or reviewing of SOP's (both new and existing)
• Authoring and/or reviewing Equipment Documentation
• Supporting Equipment Management Program
• Schedule and work with suppliers to establish equipment controls required to assure the equipment performance
• Troubleshoot manufacturing issues to identify root cause and implement corrective actions
• Generating, Reviewing, and Executing all Validation Documentation associated with our client's Validation Programs
• Collaborate with cross-functional teams to drive continuous improvement efforts
• Communicates technical information within the team
• Primarily hands-on worker
• Authoring and/or supporting efforts on any On the Job Training

WHAT YOU NEED TO HAVE:

• A minimum of bachelor's degree in and Engineering or Technical field
• 3+ years of prior experience with Equipment Qualification/Validation activities preferred; regulated industry experience, medical device or pharmaceutical experience preferred
• Strong technical aptitude and problem-solving skills
• Ability to work independently and as part of a team
• Attention to detail and ability to maintain accurate records
• Communicate effectively with cross-functional teams
  

ADDITIONAL INFORMATION:

Physical Requirements

• Lifting of up to 60 lbs.
• Standing for two hours or more
• Ability to wear and put on sterile gowning

** "SRG values your application, our team will be in touch to schedule interviews with candidates moving forward in the process."

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.