Validation Engineer I *PC 846

Your Role:

This position is responsible for adhering to the validation program, maintaining and assuring compliance with the Validation Master Plan, lifecycle process and, regulatory requirements and Site policies.

Essential Duties and Responsibilities:

• Draft and execute validation protocols (IQ, OQ, PQ, EMPQ, Aseptic Process Qualifications, etc.).
• Author validation and technical protocols, reports and develops project plans.
• Support validation and technical assessments for quality impact and participate on quality investigation teams.
• Monitor maintenance of the validated state of basic and some complex equipment and utilities via Validation Master Lists and processes. Act as an SME in client and regulatory audits, addresses audit findings, CAPAs and deviations.
• Generate, review, and assess validation final reports and addresses gaps as required.
• Conduct risk assessment, create FMEAs and other documents to justify the validation approach being taken
• Participate in change control evaluations and provides feedback on validation and/or calibration status impact.
• Perform routine gap analysis of the site's Validation and Calibration Programs to correct gaps as required.
• Manage and coordinate validation and calibration contractors to ensure the preservation of the equipment, process and facility's validated state.
• Create and revise SOPs related to the site's Validation and Calibration programs to maintain their accuracy and ensure best practices are being followed.
• Oversee computerized system validations.
• Responsible for all GMP documentation related to validation and calibration at the site activities.

Requirements:

• Bachelor's degree in engineering (Mechanical, Electrical, Chemical) or a Scientific discipline (required); 0-2 years' experience 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).
• Experience in the validation, commissioning and qualification or equipment systems is a plus.

Skills:

• Microsoft office software
• Microsoft Project
• Cleaning Validation experience is a plus

Knowledge:

• Visio is a plus

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 $72,200-$85,000/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.