LSNE Contract Manufacturing is currently seeking a Senior Engineer to join our team!
About:
LSNE Contract Manufacturing is a contract manufacturing organization with three manufacturing facilities located in Bedford and Manchester, NH as well as Madison, WI. LSNE provides lyophilization services to the pharmaceutical, biotechnology, and medical device industries.
Job Summary:
The role will interface with other LSNE functions as well as external clients to implement new processes and technologies into LSNE GMP manufacturing as well as supporting validation efforts. The individual will be a key contributor within a group responsible for performing process improvements, including timely completion of feasibility studies, scale-up, technology transfer, and GMP floor support for programs that bring new biopharmaceutical products/devices to pre-clinical, clinical, and commercial manufacturing phases.
The successful candidate will contribute during the execution of process engineering activities for the department, including troubleshooting manufacturing issues, analyzing data, and authoring technical reports. The scope includes enabling studies and contributions to the preparation of regulatory submissions. The feasibility studies include small and pilot scales to establish critical and key operating parameters including, but not limited to clinical and validation batches. The individual will effectively collaborate and communicate within the framework of cross-functional, multi-disciplinary teams. In addition, this person will interact with other internal departments such as research, internal manufacturing, facilities/engineering, project management, procurement, quality as well as with comparable functions at external clients. The individual will work autonomously to implement solutions for problems of moderate scope and complexity reporting to the Sr. Manager of MTS.
Responsibilities:
- Participate and provide input and feedback for the LSNE Safety Program to meet Health and Safety regulations and OSHA requirements in all duties
- Provide technical mentorship to junior MTS Engineers and investigators
- Experimentation and manufacturing support related work including development and pilot-scale studies to support process development, optimization, and characterization
- Contribute to the evaluation of novel, generic platform technologies that can be applied across multiple programs
- Participate during technology transfer of programs spanning all phases of biopharmaceutical/medical device lifecycle, including discussions of scale, equipment design, and oversight of GMP and Engineering batches
- Interacts with manufacturing operations staff, troubleshoots problems, and supports their operations
- Compose technical documents (protocols, batch records) for conducting technical studies
- Interpret and execute policies and procedures. Recommend modifications to operate policies
- Function as a technical expert on equipment, systems, processes
- Lead troubleshooting of operations, develop preventative maintenance procedures, and maintain engineering documentation (commissioning, protocols, test plans, functional/detailed design)
- Establish equipment specifications in standard documentation User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS)
- Lead efforts with manufacturing, process development, facilities, quality assurance, and other departments in developing requirements and recommendations for system modifications
- Execute tasks, under the minimal direction of project managers, to complete design, engineering, construction, commissioning, and qualification for projects within schedule and budget constraints
- Coordinate the work of consultants and engineering firms on the development of standard design documents
- Provide technical support to external clients and internal operations, utilizing statistical data analysis
- Develop solutions to complex problems using ingenuity and innovation, and ensures solutions are consistent with overall organization objectives
- Drive key equipment, systems, and facility improvement projects, providing oversight of design, construction, testing, and turnover with responsibility for schedule and overall project performance
- Provide technical input for product tech transfers, evaluation of process requirements versus facility capabilities
- Provide technical support and analysis for the resolution of deviations, investigations, and process issues
- Work independently to develop department procedures, standards, and specifications Writing and reviewing data summaries as per established company guidelines and procedures
- Author technical reports, technology transfer packages, and presentations
- Contribute to regulatory submissions
- Develop project scopes, schedules, and budgets
Qualifications:
- Bachelor's degree (required) Master's or Doctorate (preferred)
- 10+ years of experience in Chemical/Biochemical Engineering or related discipline within a relevant GMP manufacturing environment (required)
- 8+ years of of experience in Chemical/Biochemical Engineering or related discipline within a relevant GMP manufacturing environment with a Master's degree
- 6+ years of of experience in Chemical/Biochemical Engineering or related discipline within a relevant GMP manufacturing environment with Doctorate
- 1+ years of Process Engineering/development experience in the biotechnology/pharmaceutical/medical device industry (required)
- 1+ years of experience and practical expertise around scale-up, tech transfer, and manufacturing support to large scale GMP operations (required)
- Ability to apply knowledge of multiple engineering disciplines to evaluate and develop solutions for operational issues
- Proficiency with Microsoft products and ability to learn additional applications as needed
- Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end products
- Understanding of new manufacturing technologies including single-use disposables
- Proven track record of large scale process implementation
- Must be able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
- General understanding of fill-finish, freeze-drying (lyophilization), medical device, filtration, milling, mixing technologies, fluid metering, formulation, and purification
- Knowledge of equipment in pharmaceutical manufacturing including autoclave, filling pump, vial washer, depyrogenation oven, lyophilizers, and process utilities (WFI, PW, Clean Steam, HVAC, etc)
- Familiarity with the operation of large scale disposable technologies, devices, and production equipment for unit operations (preferred)
- Excellent verbal and written communication skills
- Strong technical writing ability required
- Excellent interpersonal, teamwork, and leadership skills
- Must be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables
Physical Requirements:
- Ability to wear personal protective equipment such as safety glasses/goggles, gloves, and safety shoes
- Ability to gown and gain entry to controlled manufacturing areas
- Ability to lift, pull, or push equipment weighing up to 25-50 lbs.
- Occasional standing is required
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Job Type: Full-time
Experience:
- Chemical/Biochemical Engineering or related discipline within a relevant GMP manufacturing environment: 10 years (Required)
- Process Engineering/development experience in the biotechnology/pharmaceutical/medical device industry : 1 year (Required)
- scale-up, tech transfer and manufacturing support to large scale GMP operations: 1 year (Required)
Education:
Location:
- Madison, WI 53719 (Preferred)
Work authorization:
- United States (Preferred)
Job distance:
- Madison, WI 53719: Between 21 and 30 miles (Preferred)