What are the responsibilities and job description for the Cleanroom Assembler position at SaniSure LLC?
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 Clean Room Assembler is responsible for assembling products and measuring parts according to specifications, blueprints, mechanical drawings, or work instructions. The Clean Room Assembler works in an ISO regulated clean room environment while wearing PPE including, scrubs, bunny suit, mask, protective eyewear, gloves, shoe covers, and similar.
ESSENTIAL FUNCTIONS:
- Maintain a sterile environment by garbing, cleaning, and performing job duties according to the CGMP guidelines for cleanroom procedures.
- Measure, cut, position, and align tubing and small components for assembly.
- Use hand tools including cable guns, tubing spreader, bag sealers, tubing cutter and other equipment to assemble parts accurately and efficiently.
- Read and interpret technical documents, such as diagrams, assembly drawings, blueprints, work instructions to identify product specifications.
- Determine sequence of assembly.
- Assemble products or components according to company standards and requirements.
- Complete required forms associated with each lot/batch.
- Inspect and clean components and finished assemblies.
- Report any issues, defects, or malfunctions to the supervisor.
- Meet daily production targets and maintain a high level of productivity.
- Follow safety procedures and company policies.
- Collaborate with team members to ensure smooth workflow and meet production goals.
- Perform other duties as assigned.
QUALIFICATIONS:
- High School diploma or equivalent desired, with a minimum of six months related experience; or equivalent combination of education and experience.
- Previous assembling experience.
- Ability to read and understand technical documents, mechanical drawings, blueprints, and bill of material (BoMs).
- Strong manual dexterity and hand-eye coordination.
- Attention to detail and accuracy in work.
- Ability to work independently and as part of a team.
- Good communication skills.
- Listens to direction and obtains clarification.
- Ability to write clearly and informatively to ensure accurate records, including batch and lot numbers.
- Able to understand assembly drawings, blueprints and bill of materials (BoMs).
- Keen eye for detail, and manual dexterity.
- Physical stamina and the ability to stand for long periods, and regularly lift and/or move up to 10 pounds frequently lift and/or move up to 20 pounds and occasionally lift and/or move up to 40 pounds.
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.