Sterility Assurance Engineering Manager

Sterility Assurance Engineering Manager

It's not what we make. It's what we make possible. And the possibilities at Lifecore are endless!

This full-time position offers incredible benefits, your choice of a 4 ½ or 5 day work week, and a company culture focused on development and growth which include promotion opportunities.

In this position you will be responsible for developing, establishing, and maintaining sterility assurance programs, policies, processes, procedure, and controls. Provide leadership to teams defining and executing equipment, process, facility (cleanroom) and sterilization (EtO, gamma) monitoring oversight and validation activities. Facilitate the personal and professional growth of technical team to meet future company needs. Ensure that Lifecore's processes and procedures meet all applicable regulatory requirements and contribute to the strategic goals of the company.

This is a hybrid role, with the option to work in the office or remotely depending on your day's schedule.

In this critical engineering leadership role you'll have the opportunity to:

• Manage creation of process, equipment, sterilization and facility validation plan/protocols and reports that are comprehensive, clearly written and technically sound and execution to plan.

• Manage team responsible for investigating, trending and reporting environmental (viable/non-viable), personnel, and utility monitoring.

• Ensure process and equipment changes are managed to maintain product quality attributes.

• Ensure risk assessments (FMEA) are performed on new/changed equipment and processes.

• Oversee creation of validation master plans and reports for facility and critical processes.

• Provide leadership for validations and investigations.

• Review and approve appropriate controlled documentation (ex. validation protocols and reports, DMR related documents, nonconformances, etc.).

• Actively seek ways to streamline processes, improve efficiencies and increase cost effectiveness.

This position could be a great fit for you if you have a passion for quality, excellent leadership skills and are a proven self-starter with excellent problem-solving skills along with the following:

• 8+ years' experience in positions of increasing responsibility in an FDA regulated industry (Biopharmaceutical or Medical Device preferred).

• Experience in Quality Engineering and/or Validation.

• Experience in medical device, drug and/or API equipment and process validation activities.

• Environmental Monitoring and cleanroom design/operation experience, APS design and execution; preferably in an oversight capacity.

• In depth knowledge and experience working with the following regulations:

• 21 CFR 820 (FDA Quality System Regulation)

• 21 CFR 210-211 (FDA Good Manufacturing Practice)

• Preferred: Experience with the following standards:

• EN ISO 13485

• ICH Q7, GMP Guide for Active Pharmaceutical Ingredients

• EN ISO14971, Risk Management

• Consolidated European Medical Device Directive (93/42/EEC)

• Canadian Medical Devices Regulations

Lifecore is a growing company and offers a highly competitive total rewards package, including:

• Opportunities to learn and grow with a well-respected company

• Competitive compensation with annual reviews and a company-wide incentive bonus

• Benefits that start the first of the month after you join Lifecore as a full time employee:

• 3 medical insurance plans to fit your needs and budget including an HSA Plan with a generous company contribution

• Low cost dental and vision insurance

• Short term disability, long term disability and life insurance all 100% company paid

• 4 weeks of PTO in the first year (increases to 5 weeks after just 2 years!)

• 9 paid company holidays (plus your birthday!)

• 4 weeks of paid family leave after 1 year of employment

• Tuition reimbursement

• 401k plan with company matching contribution

Meet Lifecore Biomedical, LLC:

For more than 30 years, we've made progress possible for patients around the world and for our employees here in Minnesota. As the global leader in manufacturing and supplying sodium hyaluronate (NaHy), more than 90 million patients have benefitted from our certified pharmaceutical grade NaHy. We are guided by an unwavering commitment to improving people's lives, including those who work at Lifecore.