Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact – one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies – transformative methods that mobilize the body’s own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.

Senior Validation Engineer I

Gaithersburg, MD

Your Tasks:

This position will take charge of maintaining and assuring compliance with the Validation Master Plan, Validation Program SOPs and regulatory requirements. This position will also manage the Qualification of various systems ranging in complexity by writing Requirement specifications, IOPQ protocols and Final reports.

Essential Duties and Responsibilities:

• Project manage, organize and coordinate qualification activities for more complex projects (i.e. qualification of an entire laboratory or Manufacturing suite) with coordination of relevant departments and or contractors.
• Author validation and technical protocols, report and develop project plans.
• Achieve solutions to complex problems, serve as a technical expert, communicate effectively, collaborate and bridge GAPS. 
• Train and provide mentorship to the junior level validation engineers in the group.
• Provide validation expertise for the development of new projects.
• Author and manage Validation program Standard Operating Procedures and Forms.
• Perform periodic reviews of Validation master plan and ensure compliance and Validation master lists and databases are maintained.
• Assure feedback of status and issues to the Validation Manager.
• Back up to the Validation Manager for Signature Authority for review of Validation protocols and documentation and Validation representative in cross functional update meetings.
• Support internal, client external audits and regulatory audits by being the validation SME and addressing all audit findings.
• Perform other duties as assigned.

Requirements:

• Bachelor’s degree (B.S.) in Engineering (Mechanical, Electrical, Chemical) or a scientific discipline with a minimum of 8-12 years related to validation and/or engineering in the pharmaceutical and/or biotech industry; working knowledge of regulations (cGMP-FDA 21CFR 210/211, 600 and/or part 11 Eudralex Volume 4); or equivalent combination of education and experience.
• Experience in the validation, commissioning and qualification of equipment systems is a plus.

Computer Skills:

To perform this job successfully, an individual should have demonstrated ability to use and operate independently within software common to Validation Departments. have knowledge of Microsoft Office Software and Microsoft Project. Knowledge of Visio a plus.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled facility. Generally, this job is performed in an office setting. The position delas with temperature controlled materials in which personal protective equipment (PPE) may be required due to extreme temperatures. All persons performing this job will receive appropriate training prior to engaging in work requiring PPE. The noise level in the work environment is usually moderate. 

As a global team of over 3,000 diverse innovators, we are united by a shared vision to advance research and improve patient care worldwide. Our mission transcends mere scientific discovery; we are on a quest to unravel the complexities of biology and transform them into tangible solutions that propel research to unprecedented heights.

Here, you will contribute to work that is breaking barriers, blending the wonders of biological discovery with the pursuit of well-being for all. Every day presents a chance to make a tangible impact and play a key role in accelerating the journey of research from the lab to the market.

Join Miltenyi Biotec and immerse yourself in an environment where your efforts are significant, your contributions are valued, and your work truly matters.

Miltenyi Biotec North America is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.