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Rapid Micro Biosystems Production Supervisor, First Shift in Lowell, Massachusetts

The 1st Shift Production Supervisor will be a working supervisor who ensures RMB meets the products' demand, production quality levels, and product yield goals. The Production Supervisor is responsible for supervising and managing production personnel, meeting and exceeding production Safety, Quality, Delivery, and Cost. This position will be responsible for developing and implementing improvements to the production process and area. This position will require being able to perform production operator duties and support/fill in whenever needed. Must be a self-starter who is comfortable working in a dynamic, team-based environment to reach common objectives with aggressive schedules.

Reports to Director of Manufacturing ? Consumables.

Duties and Responsibilities:

  • Works and maintains a safe environment and always enforces safety rules.

  • Performs supervisory tasks which include personnel assessment, hiring, training, and managing the production workforce including disciplinary functions.

  • Prepare and deliver annual performance evaluations for direct reports.

  • Develops and empowers employees to allow them to take on additional responsibilities.

  • Support materials management and manage employees to ensure a quality product is delivered on time and within standard cost budgets.

  • Understands undertakes and implements quality control/assurance techniques and procedures.

  • Supports and drives process improvements and team culture.

  • Ability to problem solve and communicate issues/resolutions to all levels of employees in the company.

  • Prepare monthly management and metric reports including budget reporting.

  • Writes/updates procedures to always ensure their accuracy.

  • Adhere to a production schedule and ensure that consumables are stocked and ready for the production day.

  • Inspect and ensure that all equipment is calibrated and in working order; balances/scales, pipettes, mediaclave, water purification systems, etc.

  • Performs and enforces aseptic techniques while following the SOPs for the filling operation.

  • Documents lot numbers, calibration, and serial numbers of all equipment used as well as any pre-fill QC; pH, temperature, water resistivity, TOC levels, etc.

  • Review and approve batch process records.

  • Sanitization of all media production equipment and areas prior to and following production work.

  • Produce production reports that track output and quality metrics.

  • Work closely with suppliers and manufacturing partners to develop and maintain efficient processes for injection molding, product preparation, and assembly operations.

  • Develop, maintain, and document processes for consumables manufacturing.

  • In conjunction with Quality, manage and provide technical expertise in response to investigating failures and performing CAPA investigations.

  • Assist as necessary to complete validations in a timely manner ensuring all relevant paperwork is completed.

  • Schedule/monitor the work performed by independent contractors and sub-contractors as necessary.

  • Perform work that is compliant with cGMP, ISO, QMS, and other pertinent regulations and directives.

  • Support immediate supervisor, and peers by anticipating problems, providing input on solutions, reacting productively to change, and handling other tasks as assigned.

  • Other duties as assigned.

    Qualifications/Experience:

  • AS or BS Degree in a technical or science curriculum that is relevant to medical or pharmaceutical operations.

  • At least 2 years of relevant industry experience working with microbiological growth media, reagents manufacturing or medical device.

  • At least 2 years of supervisory experience.

  • Excellent aseptic process/laboratory skills.

  • Working knowledge of cGMP and ISO guidelines. Familiarity with FDA regulations a plus.

  • Experience in automating and scaling manufacturing processes is required.

  • Ability to generate and adhere to a production schedule.

  • Ability to report out on production performance and actions to improve.

  • Ability to support as needed the 2nd shift production supervisor as needed.

  • Requires the ability to multi-task and maintain focus.

  • Ability to accurately write and follow procedures.

  • Must be able to communicate in English with others related to daily operations.

  • Good problem solving, math skills and ability to do mathematical conversions (Metric to English).

  • Good mechanical aptitude and skills.

  • Understanding and willingness to implement 5S and lean manufacturing techniques.

  • High degree of accuracy.

  • Ability to be gowning qualified within two weeks of starting.

Working Conditions:

  • Appropriate gowning procedures will be required (hairnet, safety glasses, clean room apparel/lab coats, latex gloves)

  • Occasional environmental odors may be prevalent

  • May be required to work extended hours and weekends

  • Must be able to lift 50 pounds

SPECIAL NOTICE: How do we protect our employees from COVID-19?

Our Lowell facility is fully CDC compliant and as well we follow the State of Massachusetts and local guidelines. At Rapid Micro Biosystems employee health & safety is our top priority. We have implemented and maintain precautions to prevent the spread of COVID-19 at our facility. We provide masks, appropriate PPE gear, and hand sanitizer to all essential employees who must report to work. Before entering the facility, employees have their temperatures checked. In addition, we take great care that all frequently touched surface areas are sanitized throughout the day, as well our facility is fully cleaned daily.

About:

Rapid Micro Biosystems creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products.

The company?s Growth Directthe first and only growth-based system to automate rapid compendial QC Micro testing?ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation.

Rapid Micro Biosystems is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.

Rapid Micro Biosystems is headquartered in Lowell, Massachusetts, with operations in Lowell and Freising, Germany.

Equal Opportunity:

Rapid Micro Biosystems is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications for a position. Under no circumstances will Rapid Micro Biosystems discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender identity, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.

Please no phone calls or agencies please.

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