Job description

Title: Cold Chain Process Manager - Onsite Role Or Hybrid depending on the State

Pay Rate: $80 - 100/hr

Duration: Temp to Hire

Location: Minnetonka, MN

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

• Develop and implement cold chain processes, equipment, and logistics to minimize time of product outside of cold chain
• Provide knowledge, experience, and training to drive cold chain industry best practices throughout the organization
• Ensure cold chain quality assurance system is in place that meets all required global regulations
• Develop and implement all documentation for cold chain processes and controls including but not limited to: standard operating procedures, batch records, training documentation, pFMEAs, process/equipment validations (IQ/OQ/PQ)
• Establish control plans to ensure cold chain requirements are met throughout manufacturing process from external component supplier shipments through device assembly/packaging and finished goods shipments
• Manage external contractors to implement and validate required facilities equipment
• Define roles and responsibilities for all employees and suppliers involved in cold chain processes
• Identify, recommend, and qualify cost effective and compliant solutions for packaging, transit, and off-site storage
• Design and develop manufacturing processes and equipment that are lean and mistake-proof
• Develop specifications and work with suppliers to quote, procure, and implement cold chain related equipment
• Develop process validation plans, lead the execution of plans, and document results in reports
• Design experiments and gather/assess/summarize data using statistical tools to make conclusions and decisions
• Lead cross-functional teams to develop and manage project plans and schedules

EDUCATIONAL REQUIREMENTS (degree, license, certification):

• Bachelor’s degree in Engineering, Supply Chain, or related technical field

YEARS OF EXPERIENCE:

• 7-10 years in cold chain process development or manufacturing in the pharmaceutical or similarly regulated industry

OTHER SKILLS AND ABILITIES:

• Experience in medical device, pharmaceutical, GMP, or regulated industry
• Ability to author technical plans and reports
• Ability to travel up to 10% as projects require
• Self-motivated with strong collaboration, interpersonal and communication skills that support success in a remote working situation
• Strong technical and project management capabilities

EQUAL EMPLOYMENT OPPORTUNITY STATEMENT:

Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.

REQUESTING AN ACCOMODATION

Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.

If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.

PAY TRANSPARENCY POLICY STATEMENT

Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.

Job Type: Full-time

Pay: $80.00 - $100.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Experience level:

• 7 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• Hybrid remote
• In-person

Work Location: In person

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