SHARP STERILE MANUFACTURING LLC Jobs in United States

The Senior Operations Engineering Manager is responsible for the technical ownership setup and consistent mechanical operation of all primary production equipment within our sterile fill-finish manufacturing facility. · This role leads a team of operations and equipment engineers ...

The Sterility Assurance Manager ensures sterility the leads contamination control program, aseptic processing simulation (media fill) program, · Oversee the Media Fill Program · Plan and design aseptic process simulations aligning with regulatory expectations, including frequency ...

The Senior Process Engineering Manager leads and oversees process engineering support for aseptic fill-finish and associated manufacturing operations at Sharp Sterile. · ...

The Quality Control Analytical Associate performs laboratory testing and administrative tasks for the QC department. · ...

The IT Manager will manage IT staff and the BSM help desk by providing technical advice and oversight for network applications for both new and existing systems at BSM. · Four (4) years related technology experience or combination of education and work experience · One (1) year ...

The Maintenance Technician is responsible for the repairs and maintenance of the facility and equipment. ...

The Director of Manufacturing balances the urgency of daily shift operations with the pursuit of long-term goals while ensuring the highest standards · of quality and compliance. Work requires excellent teamwork, ability to communicate clearly, and cooperate with other staff mem ...

The Director of Quality Operations is a critical leadership position responsible for ensuring the highest standards of quality and compliance in the sterile drug manufacturing process. This individual will lead and oversee key quality operations functions, while ensuring alignmen ...

The Project Manager facilitates all non-client site projects ensuring they are completed on time within budget and meet quality standards while coordinating with cross-functional teams. · Three to five years of experience in project management within the capital project and conti ...

The Logistics Associate is a highly organized individual who coordinates and assists multiple departments in day-to-day logistics and finishing activities. · Affordable organization skills · ...

The Operations Engineering Manager is responsible for maintaining expertise with and making meaningful contributions to filling and related manufacturing operations to meet desired product specification for all BSM client projects of parenteral drug product manufacturing. · Five ...

The Manufacturing Investigation Manager is responsible for leading and overseeing investigations associated with manufacturing deviations, · batch discrepancies, · equipment failures, · environmental events, · OOT issues, · and other GMP-related incidents.Duties include investiga ...

The QA Compliance Specialist II assists with compliance and quality activities at SSM. · Implementing cGMP and regulatory requirements at SSM. · Maintaining Quality Culture at SSM. · Provide indirect oversight of cGMP operations at SSM. · Work collaboratively within QMS to suppor ...

Maintain quality culture by supporting compliance initiatives and implementing current Good Manufacturing Practices (cGMP) and regulatory requirements. · ...

The Project Manager is tasked with establishing, maintaining and enhancing the relationship between BSM and external clients. · Exhibit a quality mindset and a willingness to develop · Demonstrated knowledge of FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requ ...

Perform visual inspection of the manufactured drug product through the packaging process including visual inspection in compliance with company policies / procedures, Food and Drug Administration (FDA) and current Good Manufacturing Practices (cGMP) regulations. · ...

The Engineering Compliance Specialist is a hands-on role responsible for overseeing and managing the investigation and on time closure of equipment deviations. · Duties include reviewing and investigating equipment-related deviations, ensuring all deviations are appropriately doc ...

The Project Management Supervisor is tasked with establishing, maintaining, and enhancing the relationship between BSM and external clients. · Masters' Degree or equivalent work experience requiredPMP Certification preferredOne (1) to three (3) years previous project management e ...

The QA Compliance Specialist I is responsible for assisting with compliance and quality activities at BSM. The role involves implementing cGMP and regulatory requirements. · Provide indirect oversight of cGMP operations at BSM · Work collaboratively within BSM's Quality Managemen ...

The Senior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes. · The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up. · The Senior Process Engineer is han ...