Manufacturing Engineer

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.

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

Position Summary:

• This is a Contract/Temporary assignment with an expected duration of 6 months

The Manufacturing Engineer works closely with Operations, Quality, and Customer Service on industrialization of products and processes. Scope includes:

• Project management and technical leadership during commercialization and post-commercial improvements to New Product Introductions, process optimization, and cost reductions.
• Leading problem-solving, corrective, and preventative actions around product and manufacturing process concerns originating both external and internal to the organization.
• Driving and facilitating assigned portions of product and process change management and control.
• Specifying and qualifying Capital equipment.
• Authoring and updating technical and process documentation as required. This includes IQ/OQ/PQ

Essential Functions:

• Analyze mechanical designs, including technical drawings and associated measurement systems.
• Work with Design Engineering and Manufacturing integrate a Design for Manufacture & Assembly and Design to Cost perspective during verification.
• Drive Capital equipment requests and qualification.
• Conduct labor and process studies. Lead yield improvements, reduce variability, support manufacturing resolving technical problems and lead cost reduction initiatives.
• Lead efforts to perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements.
• Ensure process and design changes are documented and adhere to industry quality standards. Author and update technical and process documentation as required.
• Analyze labor data against existing Standards using templates provided. Identify root causes and propose corrective actions where large variances to Standards exist.
• Interact with key company personnel both within Sanisure and external partners.
• Develop and maintain positive rapport and working relationships with other personnel across the organization in support of initiatives to execute product improvements and enhancements.
• Perform other duties as assigned.

Qualifications:

Bachelor's degree in engineering

• 5+ years manufacturing engineering experience.
• In depth knowledge of creation of 2D and 3D drawings and related Bill of Materials is desired.
• Creation of process flow diagrams.
• Creation of process control plans.
• Authoring PFMEA's.
• Project management and strong organizational and time management skills. Detail and deadline oriented.
• High initiative with the ability to work independently and problem solve with minimal supervision or direction.

• Must have a strong work ethic and ability to communicate effectively, both verbally and in writing. Strong interpersonal skills: ability to interact with staff at all levels within and external to the organization.

• Preferred experience:

• Single Use Consumable design and development experience
• Biotech device development experience.
• Process characterization experience applying Design of Experiments to optimize manufacturing processes.
• Statistical Process Control (SPC) experience.

Equal Opportunity Employer

We are committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breast feeding and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability or any other protected status in accordance with all applicable federal, state and local laws.