Fulcrum Technologies, Inc.

Fulcrum Technologies Inc. and its custom integration affiliate,
The subSolutions®Group Inc. is seeking a middle manager, for a small start-up
clean room facility to assemble “single-use” custom components and assemblies
for the BioTech industry market segment. This expansion is designed to extend our
in-house capability for assembling new applications that will complement existing significant
outsource business.
Your Qualifications – B.S. degree with a minimum of 3-5 years relative experience in BioPharm market
segment is required. You will be expected to be technically astute, along with having strong organizational
and people skills. Experience in silicone assembly manufacturing in a GMP environment important.
Must be reliable, flexible and open to change. The position includes:

Interfacing with customers’ quality auditing requirements and issues.
Executing and responding to customer supplier Quality Assurance questionnaires and/or live auditing requirements.
Standard Operating Procedures (SOP’s) -- maintaining and amending SOP’s for our entire production including clean room cleaning/maintenance receiving and inspection of component material, assembly, inspection/packagingof final assemblies. Coordination of outsourced sterilization in concert with internal SOP’s.
Capability to understand, adhere to and train others to GMP’S/ SOP’s and clean-room assembly.
Creating and maintaining Work Instructions for production.
Capability and willingness to perform production assembly as needed.

Compensation—We offer a competitive salary and currently offer benefits package of
Health and Life insurance plans with respected first-rate providers. We provide
401k Retirement Plan with Employer Match when vested. We are a company committed to a smoke-free environment.
Please provide resume, salary history and requirements with cover letter expressing your interest and qualifications to hr@fulcrumtechinc.com .