Validation Engineer - BioManufacturing
Location:
Marlborough , Massachusetts
Posted:
December 17, 2016
Reference:
2752152
Job Number

2752152

Business

GE Healthcare

Business Segment

Healthcare Life Sciences

About Us

What do you envision for your future? At GE Healthcare, we strive to see life more clearly. Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access and improving quality and efficiency around the world.

We are an $18 billion unit of General Electric Company (NYSE: GE), employing more than 52,000 people worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy - and we'd like you to be a part of it. As a global leader, GE can bring together the best in science, technology, business and people to help solve one of the world's toughest challenges and shape a new age of healthcare.

Something remarkable happens when you bring together people who are committed to making a difference - they do!

At work for a healthier world.

Learn More About Careers at GE

Learn More About GE Healthcare

GE Healthcare Life Sciencesprovides products and services used as tools for biopharmaceutical manufacturing, drug discovery and the latest in cellular technologies, thereby enabling our customers around the world to be more productive, effective and creative. Our motivation is to create better health for more people. Through our five decades of supporting the biopharmaceutical industry and its research partners to become more productive, we are helping to reduce costs, increase access and improve quality in the healthcare system. We use our expertise and know-how in imaginative ways to work with our customers to provide what's needed today and create products and solutions to enable the medical treatments of tomorrow. We add value to our customers by:

* Providing cutting-edge research tools that give deeper insights into cell function to enable disease diagnosis and the development of treatments.

* Enabling manufacturing productivity: we provide solutions for the entire bioprocess workflow (i.e. start-to-finish bioprocessing) helping our customers to develop and manufacture biopharmaceuticals more efficiently.

* Providing high quality support and maintenance services.

We are the home of many famous brands, including Whatman, Amersham, Biacore, WAVE, Applied Precision, Xcellerex and more.

Learn More About GE Healthcare Life Sciences

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Posted Position Title

Validation Engineer - BioManufacturing

Career Level

Experienced

Function

Manufacturing

Function Segment

Manufacturing Engineering

Location(s) Where Opening Is Available United States

U.S. State, China or Canada Provinces

Massachusetts

City

Marlborough

Postal Code

01752-7217

Relocation Assistance

No

Role Summary/Purpose

The Validation Engineer for BioManufacturing Services has responsibility for a variety of validation activities, including: generating and executing qualification protocols; improving, revising and implementing validation policy; and assuring appropriate qualification status of equipment and systems in an expanding biomanufacturing facility.

Essential Responsibilities

• Assists in developing and implementing the validation plan for new and existing facilities

• Assists with updates to the Validation Master Plan

• Ensures that existing equipment and utilities are sufficiently qualified

• Streamlines qualification protocols and generation process

• Generates and performs qualification protocols and produces validation reports

• Assumes responsibility for aspects of the calibration program on an as needed basis

• Improves and tracks the revalidation program

• Encourages and suggests process improvements

• Completes other tasks as assigned

Quality Specific Goals:

1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

2. Complete all planned Quality & Compliance training within the defined deadlines

3. Identify and report any quality or compliance concerns and take immediate corrective action as required

4. Knowledge and understanding of document control, verification, validation, acceptance activity, requirements to ensure compliance to validation, design and production requirements.

Qualifications/Requirements

• Bachelors of Science degree in a related science or engineering field

• Minimum of five years in a biomanuacturing operation in a manufacturing, engineering or quality role with at least three years of hands on validation experience

• Working knowledge of temperature mapping equipment (e.g. Kaye Validator)

• Strong working knowledge of cGMP regulations and ICH guidance regarding validation policy and have sufficient experience with manufacturing equipment and utilities to understand how to design efficient qualification protocols.

• Ability to work effectively and independently to ensure that validation programs are completed on time and with efficient use of resources.

• Ability to work effectively in a matrix organization, borrowing and directing resources to supplement his or her effort to complete validation work.

• Must understand technical oral/written English

• Project and time management skills.

• Excellent spoken and written communication

Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.

Desired Characteristics

• Bachelor's Degree in a related science or engineering field

• Knowledge of 5S, Lean manufacturing

• Line management experience, experience generating validation policy, project management.

• Prior experience in a small biotechnology company or CMO environment is beneficial

• Experience with single-use systems is preferred

A little about us:
GE imagination at work.

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