Location: Lowell,MA, USA
Winning the race to bring new healthcare products safely to a waiting world drives Rapid Micro Biosystems (RMB) to combine today's innovative technologies as never before. Your career at RMB puts you at the center of diverse global teams that span robotics, AI, Machine Learning, imaging, microbiology, and more, re-shaping how urgently needed pharmaceuticals are made, tested, and released for decades to come. The sky's the limit.
Careers at RMB are fast-moving, with the high growth you'd expect from a world leader in microbiology automation. Advancement at RMB affords an opportunity to achieve your personal goals and develop your passions, in an inclusive environment where every employee has the resources and opportunities to hone their skills. You'll do more, learn more, and have the ability to make a profound impact on our business.
The 2nd 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 Manager 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. (approximately 9 direct reports)
* Prepare and deliver annual performance evaluations for direct reports.
* Develops and empowers employees to allow them to take on additional responsibilities.
* Schedule/monitor the work performed by production team (including independent contractors and sub-contractors as necessary).
* Support immediate Manager, and peers by anticipating problems, providing input on solutions, reacting productively to change, and handling other tasks as assigned.
* Support materials management and manage employees to ensure 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.
* Develop, maintain and document processes for consumables manufacturing.
* 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.
* 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.
* Perform work that is compliant with cGMP, ISO, QMS and other pertinent regulations and directives.
* SAP experience is a plus. Should be able to reconcile PHR's and enter transactions, labor and goods movements, review and technically complete jobs in SAP.
* Ability to preform production operator duties and support/fill in when necessary
* 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 supervisory experience required
* 2 years of relevant industry experience working with microbiological growth media, reagents manufacturing or medical device is a plus.
* Excellent aseptic process/laboratory skills.
* Working knowledge of cGMP and ISO guidelines. Familiarity with FDA regulations a plus.
* Ability to generate and adhere to a production schedule.
* Ability to report out on production performance and actions to improve.
* 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.
* SAP experience/knowledge.
* High degree of accuracy.
* Be a self starter, self motivated to get things done.
* Ability to be gowning qualified within two weeks of starting.
Working Conditions:
* Expected Shift Hours: 3:30pm - 2:30am
* 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 pou
ABOUT RAPID MICRO BIOSYSTEMS:
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 Direct-the 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 Lexington, Massachusetts. Our research & development, and manufacturing operations are located in Lowell, Massachusetts. Additionally, we maintain field offices in Freising, Germany; Switzerland, and Singapore.
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.