Validation Consultant Position Available In Suffolk, Massachusetts

Validation Consultant Imperium Life Sciences Boston, MA Job Details Full-time | Contract $140

• $190 an hour 3 hours ago Qualifications Engineering ICH Q9 Master’s degree Bachelor’s degree System validation Cleaning Senior level FDA regulations 10 years Full Job Description Validation Consultant 6-12 month contract

Rate:

$140

• $190 Boston, MA
• ONSITE Pharmaceutical company Start date: ASAP I’m working with a Pharmaceutical Manufacturing company who are on the lookout for a Validation Consultant to join their team in Boston, MA.

This is a medium sized pharmaceutical company, but they are investing heavily in their staff and their infrastructure to be able to grow into a well-known household brand. This company already has a global presence and works with a wide array of clients themselves. These vary from small startups to some of the biggest names in the world, and you could be a part of this growing company. If you want to become a part of a team that invests in it’s staff to improve the overall company, that has clear paths of progression to promotions and a company that has committed to an impressive amount of growth in the next 5 years then this could be the company for you.

Responsibilities:

• Help write qualification documents like protocols, summary reports, user requirements (URS), specs, traceability matrices, and more.
• Follow and carry out the Validation Master Plan and project plans.
• Assess risks for new or existing systems to figure out if more testing is needed.
• Team up with QA and other departments to create system requirements (like URS, FRS, and SDS) for GxP systems.
• Create and run qualification test protocols (IQ, OQ, PQ).
• Support the qualification of new equipment, including lab instruments.
• Review planned system changes—like updates to software or configuration—to see how they affect validation.
• Take ownership of change control and CAPA tasks, and make sure they get done on time.
• Troubleshoot issues that come up with GxP electronic systems.
• Make sure validated systems keep meeting IT and Quality standards—like managing changes, backups, disaster recovery, and access control.

Required qualifications:

• Bachelors or masters in engineering (or scientific field)
• 10+ years if validation experience
• 10+ years qualification experience
• 5+ years in a regulated field
• In-depth knowledge of regulatory guidelines (FDA, EMA, and ICH) good knowledge of validation methodologies such as risk-based validation, process, cleaning, and computer systems.
• Experience with 21 CFR Part 11 & 211, ICH E6(R2) & ICH Q9, and EudraLex Annex-11

Job Types:

Full-time, Contract Pay:

$140.00

• $190.

00 per hour

Schedule:

Day shift Monday to

Friday Work Location:

In person