Manager, Quality Assurance (Engineering) *PC 1428

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. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.

Your Tasks:

This position leads, designs, performs, and reports validation activities on equipment and systems that are used in the manufacture of product for domestic and international markets.

Essential Duties and Responsibilities:

• Review Facilities, Engineering and Validation project design, user requirements and commissioning documents. Advise senior management on findings and recommendations related to Quality, Facilities, Engineering and Validation issues.
• Review and approves cGMP documentation including procedures, validation protocols, reports, development reports and other related documents.
• Develop and maintain metrics and trending reports for compliance-related activities.
• Participate and/or coordinate compliance assessments of departments, as necessary (GXP, Part 11, etc.).
• Lead continuous improvement objectives to ensure compliance with government regulations.
• Assist with the CAPA, Calibration, Preventive Maintenance and Change Control Systems oversight.
• Oversee the performance of designated staff, including interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.

Requirements:

• Bachelor's Degree in the life sciences with four to six years' experience, master's degree in the life sciences with two to four years' experience preferred; 8 years' experience in biotech, biological, pharmaceutical, or other cGMP-regulated industry with at least 3 years in an engineering, validation, manufacturing operations or quality assurance role; or an equivalent combination of education and experience
• Excellent oral and written communication.
• Knowledge of cGMP regulations and validation principles.

Skills:

• Ability to work well in a fast paced, team-oriented environment interfacing with internal and external clients while meeting timelines.
• Demonstrated knowledge of Quality Assurance Database software, Project Management software, Spreadsheet software and Word Processing software.

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, or crawl. The employee must occasionally lift and/or move up to 15 pounds. 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.

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, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.

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.

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. 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, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.