Director of Engineering

2 months ago

Camarillo, 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 Director of Engineering leads multiple engineering teams supporting commercialized single-use solutions for the bioprocessing industry. This is a global role is accountable for sustaining engineering, design revisions, drafting, BoM maintenance, configuration management, manufacturing engineering, labor cost estimating and value engineering across multiple sites.

ESSENTIAL FUNCITONS:

  • Manage and oversee all operations and aspects of engineering including Process Manufacturing Manager, Sustaining Engineering and Drafting Lead. Works closely with R&D, Operations, Quality and Product Management
  • Organize and supervise the hiring, training, and scheduling of team members
  • Establish and implement engineering practices, processes, goals, and objectives
  • Represent Engineering as a key contributor to the Strategy Deployment Process
  • Build and foster business relationships with internal and external stakeholders
  • Develop and coordinate engineering projects and strategies
  • Manage and oversee the department’s financing, expenses, and budgeting
  • Lead engineering projects by setting objectives, requirements, and timelines
  • Research and implement innovative technologies to improve the department’s success
  • Evaluate the performance of engineering team members
  • Collaborate with the Executive Leadership Team about important matters and any issues that may arise
  • Coordinate and monitor engineering projects to ensure schedule and budget performance
  • Oversee the development, deployment, revision, and control of Engineering SOPs
  • Provide technical guidance and assistance to engineering team members
  • Ensure robustness of pre-production verification and validation testing during new product introduction process as an active participant in technical and phase gate reviews
  • Advocate and integrate a Design for Manufacture & Assembly perspective during pre-production verification
  • Oversee efforts to perform root cause analyses, resolve and implement product fixes, modifications, and design enhancements
  • Manage team of Engineers ensuring full documentation of design including drawings, BoM, change control, specifications, and manufacturing work instructions
  • Ensure process and design change documentation and notification meets industry design control standards
  • Lead and guide technical teams addressing audit findings, CAPAs, NCRs, and remediation of existing design files to address changing regulations, obsolescence, and/or changing test requirements
  • Oversee customer complaint investigations and build processes that analyze complaint data, Pareto and address systemic design issues Propose design changes to resolve issues, manage implementation and monitor effectiveness
  • Develop strong product knowledge to provide technical expertise to other functional areas
  • Champion yield improvement, variance reduction and process optimization initiatives
  • Advocate supplier and component redundancy, design changes to reduce manufacturing cost, lead-time, and quality issues
  • Lead technical oversight of supplier changes to processes, design, and/or materials
  • Manage technical support required to provide customer change notification and resolve supplier and/or field issues.
  • Ensure engineering processes and practices achieve product compliance (REACH, ROHS, CE, etc.)
  • Perform other duties as assigned

QUALIFICAIOTNS

  • Bachelor’s or Master’s degree in a relevant engineering field
  • 8+ years experience in an engineering environment including industrialization of new products, drafting, design control, risk management and manufacturing engineering
  • Demonstrated in-depth knowledge of engineering best practices and processes in a regulated industry
  • Outstanding leadership and motivation skills
  • Strong people skills: ability to interact with staff on all levels
  • Strategic mindset
  • Exceptional project management skills
  • Proven presentation skills and ability to communicate effectively, both verbally and in writing.
  • Experience working in a GMP (Good Manufacturing Practice), cleanroom and/or laboratory environment


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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