****Looking for candidates with 5+ years of engineering experience within one of the following disciplines: - Pharma/Biotech (biologics highly preferred) - Medical Device (orthopedics highly preferred) Candidates with experience outside of either Pharma, Biotech, or Medical Device cannot be considered for this position unfortunately. The Process Engineer is responsible for providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at the manufacturing site. Equipment may include major processing equipment such as bioreactors, tangential flow filtration, chromatography, filling equipment, support systems such as incubators, freezers biosafety cabinets, offline benchtop instruments or facility/utility systems. This individual will be required to develop an understanding of current and future processes and translate these into the facility and equipment requirements at the manufacturing site. Responsibilities Ensuring new equipment is appropriately designed/qualified and existing processes runs in a compliant manner through equipment lifecycle. To include: Investigating any equipment or process deviations. Developing corrective actions to prevent reoccurrences. Appropriate change management for any changes to qualified systems. Owns and manages changes to the process equipment to maintain equipment in a validated state. Problem solve any technically related issues impacting production. Develop and implement equipment reliability and maintenance strategies that are compliant, effective and cost appropriate. Routinely monitor equipment performance. Develops project objectives working with user requirement and business plans. Determines project specifications and appropriate technologys to be implemented. Establish equipment specifications in standard documentation User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS). Support investigation non-conformances associates with equipment, facility or utility systems. Participate in all FDA and internal audits of the manufacturing facilities and process equipment and respond to any observations received. Responsible for maintaining quality standards to meet GMP requirements, CFRs and internal company policies with respect to equipment systems. Represent process engineering and validation in any technology transfer activities. Responsible for either leading or providing SME support on capital related projects. Qualifications Minimum B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, or 4 years of equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations. Experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology. In-depth knowledge of FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility. Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products. Excellent oral and written communication skills. Strong technical writing ability required. Associated topics: bioengineering, biological engineer, biomedical, bioprocessing, medical, molecular, neurodegenerative, nutrition, pain, pathogenesis
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.