Commissioning & Qualification Engineer

You'll be part of the leading experts in environment that pride themselves on grit, integrity, ownership, and innovation.

Germfree prides themselves on engineering and developing innovative solutions that make an impact out in the real world.

You will perform commissioning, qualification, and validation (CQV) testing on modular and mobile cGMP manufacturing, biocontainment and healthcare facilities and equipment.

The Validation CQV Engineer authors protocols, initiates-controlled documentation throughout client projects either independently or as part of a larger team including with CQV partners.

Responsibilities include generation of documents such as master plans, design qualification, factory and site acceptance protocols, commissioning and qualification of facilities, utilities, and equipment, and development of final reports.

This position is hands on. The candidate will be required to coordinate and schedule work with all impacted departments, execute this work in an efficient manner, generate and manage project timelines, research specifications, and generate documentation that meets cGMP regulatory requirements for the pharmaceutical, healthcare and biocontainment industries.

The candidate must also be able to work well as a team member, often interacting and collaborating with other Germfree departments, subject matter experts, engineering firms and clients.

Responsibilities and Duties :

• Technical knowledge of MEP system design and operation,
• Experience with commissioning plans, checklists, pre-functional and functional test procedures, plant and facility start-up, staff training, and operating and maintenance manuals, etc.

Reviewing client project requirements.

• Supporting and documenting design reviews.
• Creating commissioning plans, checklists, and tests.
• Performing field visits, performing, and observing commissioning tests.
• Writing field reports and final reports.
• Performs commissioning, qualification, and validation testing (protocol execution) on facilities, utilities, and manufacturing equipment.
• Reviews equipment specifications, manuals, and develops an understanding of how instruments work; tests equipment accurately to meet requirements for intended use.
• Review and approve protocols, exception reports, and summary reports.
• Perform cost estimates for project deliverable.
• Performs system walk-downs and makes changes using the change control process.
• Supports the preparation, review, and closeout of turnover packages.
• Generates analyses and summary reports.
• While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls;

reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.

• Must be able to lift and / or move up to 40 pounds.
• Specific vision abilities required by this job include close, distance, peripheral, color perception, and the ability to adjust focus.
• Regularly works with moving mechanical parts and may work with chemicals.
• Multi-week travel will be necessary to client locations. Some international travel may be required.

Required Skills and Abilities :

• Excellent technical writing and communication skills.
• Knowledge of clean room classifications and standards.
• Understanding of 21 CFR Part 11 requirements and GAMP 5 guidelines.
• Understanding of MEP systems.
• Understanding of control systems.
• Understanding of aseptic processing equipment.

Education and Experience :

• Degree in related engineering or life science discipline.
• Experience working within the pharmaceutical, biotech and / or medical device industry.

Supervision Required : Medium - Ability to work independently or with others to complete tasks on schedule.

Supervisory Responsibilities : None

Work Schedule / Environment : Full Time Permanent Position. Multi-week travel will be necessary to client locations. Some international travel may be required.

Why You'll Love Germfree : We want to make sure that you can expect excellence from us as well, and so we provide the best work environment possible to allow you to love what you do.

As stated before, we will give you everything you need to succeed, and will also motivate you to push yourself in new and positive ways.

Whether this is meeting new people, working on projects you are passionate about, or innovating a process - we will help make it happen.

A super hardcore work ethic, talent for building things, common sense & trustworthiness are required. At Germfree, you will get out exactly what you put in, and we know you can excel with us.