Description

The Validation Engineer (Upstream/Downstream Equipment Process) will be integral to the qualification of process equipment at our BioPharma manufacturing center in Milford, MA. This role involves leading small to medium-sized project activities, including design review, startup, commissioning, and qualification/validation of both new and existing manufacturing operations. The ideal candidate will have hands-on experience in developing and executing specifications, operating procedures, and CQV protocols to maintain system validity.

Company Culture and Environment

Our work environment fosters collaboration and innovation, emphasizing hands-on involvement and technical expertise. We value proactive problem-solving and encourage team members to contribute ideas for improvement.

Career Growth and Development Opportunities

This position offers opportunities for professional development within the BioPharma industry, allowing you to enhance your skills and advance your career through exposure to diverse projects and technologies.

Detailed Benefits and Perks

While specific benefits are not detailed in the job description, our company typically provides comprehensive support for employee wellbeing and professional growth.

Compensation and Benefits

• Pay Rate: $60.00/hr on W2
• Potential for Temp to Hire after 6 months

Why you should apply for this position today

This role provides a unique opportunity to contribute to the growth of a cutting-edge BioPharma manufacturing center while developing your expertise in validation processes. By joining our team, you will play a key role in ensuring the quality and reliability of essential pharmaceutical equipment.

Skills

• Proven experience with Upstream/Downstream process equipment qualification (e.g., Buffer Prep, Media Prep, Bioreactors, Filtration Systems)
• Strong background in writing, reviewing, and executing CQV validation protocols and technical reports
• Excellent communication and teamwork skills
• Ability to manage multiple projects effectively

Responsibilities

• Lead activities for design review, startup, commissioning, and qualification/validation of process equipment
• Develop and execute specifications and operating procedures
• Maintain System validity through comprehensive CQV documentation and protocols
• Provide expertise in CQV documentation for contract development and manufacturing organization (CDMO)

Qualifications

• Minimum of 5 years of hands-on validation experience in pharmaceutical/biotech industries
• Minimum education: Bachelors degree in Engineering, Life Sciences, or related discipline (Chemical Engineering, Chemistry, Biology, Electrical, Mechanical, etc.)

Education Requirements

• Bachelor’s degree in Engineering, Life Sciences, or a related discipline

Education Requirements Credential Category

• Bachelors Degree

Experience Requirements

• Minimum of 5 years of direct validation experience in the pharmaceutical/biotech industries

Why work in Milford, MA

Milford, MA offers a charming suburban environment with easy access to the vibrant cultural and recreational opportunities of the greater Boston area. Enjoy a balanced lifestyle with a strong sense of community, excellent schools, and beautiful parks, making it an ideal place to live and work.