Lead Cleanroom Assembler

2 months ago

Sparta, United States SaniSure LLC Full time
Job DescriptionJob Description

ABOUT SANISURE

SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations in the U.S. and in Europe, SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Its single-use products and system solutions are sold to global pharma and biotech companies and are used from R&D through full-scale commercial cGMP manufacturing of among the most innovative large molecule therapeutics and vaccines. This role is expected to be on-site.

We continue to be on a robust growth trajectory, via both organic and inorganic growth, as the company capitalizes on increasing global demand and continues its transition from a component manufacturer to an integrated systems and solutions provider.

Our primary offering includes high-value assembly solutions and a portfolio of market-leading products, including PharmaTainer bottles and carboys and related assemblies, Mixed4Sure mixing solutions, Flex4Sure bags and bag assemblies, Fill4Sure needles and needle assemblies, fittings, clamps and a wide range of silicone, braided and thermoplastic tubing solutions. The company has a growing portfolio of innovative solutions serving fast-growth applications, such as cell and gene therapies.

SaniSure is a high-growth, nimble and innovative company with a strong customer and market focus. Join us and grow your career at SaniSure

SUMMARY:

The Cleanroom Assembler Lead supports the Clean Room Manager by overseeing the training and mentoring of the clean room assemblers and establishing prioritization of customer jobs being while ensuring that all procedures are followed meticulously to maintain cleanliness and adhere to quality standards.

ESSENTIAL FUNCTIONS:

  • Provide day-to-day guidance, training, and support to ensure Cleanroom Assemblers perform their tasks accurately and efficiently.
  • Manage the assembly process within the cleanroom, including organizing workflow, and ensuring that production targets are met while maintaining high-quality standards.
  • Ensure quality of assembled products is paramount by conducting regular inspections, implementing quality control measures, and addressing any issues or deviations from standards promptly.
  • Communicate deviations, production, quality and performance issues to Clean Room Manager.
  • Identify training needs and implement programs to develop the skills and knowledge of clean room assemblers.
  • Facilitate communication and collaborate among team members, other areas of the organization.
  • Maintain the cleanliness and integrity of the cleanroom environment. This involves following strict protocols for gowning, cleaning, and sterilization to prevent contamination of products.
  • Ensure team members adhere to safety protocols and clean room environment regulations to maintain a safe working environment.
  • Recommend ways to optimize assembly processes, enhance product quality, and increase efficiency, including new technologies, tools, or methodologies to drive positive changes.
  • Identify and mitigate potential risks and vulnerabilities that may impact operations.
  • Identify and resolve problems in a timely manner by gathering and analyzing information skillfully.
  • Maintain a sterile environment by garbing, cleaning, and acting according to the CGMP guidelines for clean room procedures.
  • Work in the clean room performing tasks of clean room assembler, as needed.
  • Perform other duties as assigned

QUALIFICATIONS:

  • High School diploma or equivalent desired, with a minimum of 2 years related experience; or equivalent combination of education and experience.
  • Ability to inspire and motivate team members by providing direction and leading by example, creating a positive work culture.
  • Clear and effective communication skills to convey goals, expectations, and feedback.
  • Adept at identifying challenges, analyzing root causes, and developing practical solutions.
  • Capable of making timely and well-informed decisions, based on available information.
  • Effective time management skills to prioritize tasks, allocate resources and consistently meet deadlines.
  • Possess industry-specific knowledge on how to assemble intricate parts or products in a controlled room or facility.
  • Attention to detail with accuracy and thoroughness.
  • Ability to read and interpret written information including BoM’s and mechanical drawings to identify product specifications.

SaniSure is an Equal Employment Opportunity Employer.

SaniSure does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age, military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at humanresources@sanisure.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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