Validation Engineer III *PC 847

Your Role:

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 equipment, facility, systems and for computerized systems.

Essential Duties and Responsibilities:

• Manage the full lifecycle of systems validation projects including but not limited to delivering on time and to specification.
• Project manage, organize and coordinate full lifecycle validations for more complex projects (i.e qualification of an entire laboratory or Manufacturing suite) with coordination of relevant departments and or contractors.
• Write and assist in writing all validation deliverables within the equipment, facility or systems, e.g. User Requirement Specifications, Validation Plans, qualification protocols, Risk Assessment, Summary Reports.
• Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate & site quality management system and current industry practices.
• Achieve solutions to complex problems, serves as a technical expert, communicates effectively, collaborates and bridges GAPS.
• Coordinate project meetings, steering committees, workshops and production of related documentation i.e. minutes of meetings, project plans etc.
• Train and coach staff in relation to systems as required.
• Author and manage Validation program Standard Operating Procedures and Forms.
• Perform periodic reviews of Validation master plan and ensures compliance and Validation master lists and databases are maintained.
• Assure feedback of status and issues to the Validation Manager.
• Support internal, client external audits and regulatory audits by being the validation SME and addressing all audit findings.

Requirements:

• Bachelor's Degree in Engineering (Mechanical, Electrical, Chemical) or a Scientific discipline (required) or a Master's degree in related fields, Continuous improvement certification; 5-8 years' experience related to validation and/or engineering in the pharmaceutical and/or biotech industry, or 3 years' experience with a Master's degree; Working knowledge of regulations (cGMP-FDA 21CFR 210/211, 600 and/or part 11Eudralex Volume 4); or equivalent combination of education and experience.
• Experience in the validation, commissioning and qualification or equipment systems is a plus

Knowledge:

• Visio
• MS Project
• Kaye
• Ellab

Skills:

• Demonstrated ability to use and operate independently within software common to Validation Departments
• Microsoft office suite (Word, Excel, PowerPoint)

Physical Demands:

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Working Environment:

This position deals with temperature-controlled materials in which personal protective equipment (PPE) may be required due to extreme temperatures. Employees must wear appropriate clothing and protective equipment such as masks, glasses and gloves when entering the manufacturing and/or laboratory environment.

The hiring range for this position is expected to fall between $108,400-$127,500/year reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

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

Miltenyi Biotec, Inc participates in E-Verify.

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.