Technical Services Process Engineer

Cook Medical - Pittsburgh, PA3.6

Overview Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Technical Services Process Engineer. The Technical Services Process Engineer is responsible for process flow from the evaluation to implementation of continual process improvements including the successful transfer of product development activities to full scale manufacturing activities.

Responsibilities • Serve as the bridge between Product Development activities and GMP manufacturing implementation
• Utilize systems to ensure appropriate use of quality risk management in the design and evaluation process
• Utilize systems to ensure design and quality objectives of projects and initiatives are defined prospectively and subsequently met prior to implementation
• Ensure accuracy and integrity of scientific work performed within department
• Provide technical training as necessary to operators
• Provide on-the-floor oversight of the manufacturing process, as necessary

• Interact with Product Development technical team to understand bench and pilot-scale data
• Oversee the appropriate scaling and transferring of processes based on data
• Ensure the appropriateness of equipment and components to perform manufacturing
• Develop technical documentation to describe transfer of data to implementation of manufacturing processes
• Interact with technical representatives as necessary

• Write or direct the writing of GMP manufacturing documentation, including Process Batch Records, Media Formulation records, Sample Plans, Bills of Materials

• Work as part of operational excellence team to routinely assess the need for system improvements
• Monitor process data, identify trends, present data, and propose action as necessary
• Perform and document formal deviation investigations as needed
• Where needed, develop additional scientific and technical expertise and capabilities as necessary for project management and completion
• Work with auditing team to process improvements as necessary

• Support investigations of process-related manufacturing deviations and investigations
• Perform technical troubleshooting
• Act as a resource to provide technical and scientific troubleshooting and other support to company departments, as needed, for CAPAs, investigations, follow-ups to investigations, and implementations

Qualifications • Bachelor's degree in Life Sciences or Engineering at minimum; advanced degree preferred
• 3+ years of experience managing and leading projects or relevant experiences within the biopharmaceutical or healthcare industry
• Must possess excellent organizational skills and the ability follow complex processes, procedures and systems
• Demonstrate critical thinking and ability to execute goals set by the organization and Department Manager

• Proficiency in MS Office and other general office equipment
• Must maintain a high level of professionalism, business acumen
• Must have effective verbal, written and interpersonal skills
• Maintain composure and competence under stressful situations; flexibility and adaptability
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

Physical Requirements:

• General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time
• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting
• Ability to conduct and hear ordinary conversation and telephone communication
• Visual and manual acuity for working with computers and equipment
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations

• Must be able to lift/push/pull up to 25 pounds on an occasional basis with or without reasonable accommodations
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on a regular basis
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
• Ability to work under specific time constraints