Sr. Process Engineer
Location: US, NC, RTP 
Department: biotech
Employment type: Contract
Required experience: Mid-Senior level
Required education: Bachelor's Degree
Industry: Biotechnology
Function: Engineering
Company profile: Maynard Consulting Company has more than 20 years experience in the biotechnology, pharmaceutical, medical device, chemical, and validation engineering fields. In addition, we have over 10 years in project management, software engineering, telecommunication, testing, and networking engineering.  MCC partners with skilled candidates to meet and exceed their career expectations.
Description: The Production Department is responsible for the production of sterile injectable mixtures, inhaled products (MDI, pMDI, DPI, and nasal), and other formulations compatible/accessible with the production equipment available at the Client’s Morrisville site.  This includes maintenance, setup, operation, changeover, and routine maintenance of automated and manual production equipment.  The Production Department executes, completes, and reviews all associated master batch record documentation; creates and reviews standard operating procedures; creates manufacturing metrics documentation and assists with process development and validation studies.The position is a manufacturing core team leader supporting the commercial manufacturing process and equipment expansion, as well as ongoing operations.   This position will be responsible for all technical and operational elements of the new commercial inhalation manufacturing process including:   process engineering and troubleshooting, process and product improvement, equipment selection and usage, capacity utilization improvement, lean process design, ensuring delivery to customer specifications and timelines, and customer, supplier and communications.   This technical leadership role will work to deliver customer satisfaction and, with the cross functional core team, will deliver the product on time, with high quality, and at the correct cost.  This position works closely with all site organizations and with the customer. 
Requirements: III.  Specific Duties, Activities, and Responsibilities    1.Utilize Six Sigma and Lean to integrate new products into the #URL_00b313472b1dbc555b53b09bbbb9a17586c439aa6221bea0083a8051328c70af# activities and project deliverables across operations and #URL_3d5ffea8b80e04b18d46576a7e1a73492b4049108815e69e1353f2d993f6fc24#.Develop and drive production processes to meet customer #URL_860ff9c461988685b2bca88d05f5654d55a5e8f6142abf7674b00c2c51921a39#.Assemble, facilitate and participate in cross functional #URL_292226f934a2786220c9e0f172399f5fe5bd5dfe9516390206ce5f41ae843dc4#.Process troubleshooting and #URL_e27faff18b1e9d11b5f67ad1a2447b962faf17fc57f07a6bd3e0ea09caba9cfe# critical dependencies and risks; develop risk mitigation #URL_847764da9202d8b7368a1ef77ea0a031ea7bb340ba7f55030b59066b32c0e289# EH&S in all design and process #URL_d00b7d42e37df402c74e8d7ae7997a6a9880754448ffaf318d1fd23e8c18ad67# and implement project performance tracking and reporting tools9. Define critical process parameters, operational ranges and acceptance for quality assurance and process validation #URL_486d0cb62c512e5b1b0584a51c7e36e8e3086453060d0d58f37b0c5e6689bf41# and coordinate activities of manufacturing personnel to ensure projects progress is on schedule and within #URL_bdf1faf8665248938b3a3660ed089b74f59e5abc51ea37a9b805a60dc14c3422# group is compliant w/ all regulatory #URL_ee60403e74001e9c2472732c4fbbfbefe7de83034a834617f088162362c53d62# and resolve technical and/or program #URL_e3bf066ab57c5935885cb5659a1bea28b40dc28e37e1ebe9f7f2f7aba6cefcc4# effectiveness of the Quality System, be prepared for internal, external and customer audits at all #URL_3693cb2067e627a35f7d64f3e1c7249e06c9577a47f913362953817b6520d541# performance and development of team #URL_9fb541e573af32ad59748bd9499933e59fcd4451860afb458a67baa0715590ad# other duties as assigned.    Education and Experience:   Bachelor of Science in Science/Operations Management/Engineering or relevant discipline required with 10 years experience in pharmaceutical operations.Leadership experience with production employees.Experience with inhalation (MDI/DPI) manufacturing a plus.Program management expertiseKnowledge of change control and process validation is required.Experience with inhalation manufacturing technology, processes and packaging.Experience working in a cGMP controlled environment.Excellent communication and documentation skills.Six Sigma / Lean Manufacturing / Professional Project Management skills a plus.Ability to assess risks (program, technical, sterility) and take appropriate corrective actions.  Technical customer interaction Knowledge, Skills and Abilities:   Ability to handle multiple tasks and work in a highly matrixed environmentStrong problem solving and analytical skills in a process / manufacturing-based environmentUnderstanding of statistical process control and improvement methodologies.High level of attention to detail and excellent documentation skills.Ability to work on a cross functional team to achieve a common objective.Strong communication skills; both written and oral.Motivational skills, ability to lead past obstacles and creatively solve problems.A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred.Must possess appropriate broad communication skills allowing direct interaction with production employees, outside suppliers, internal stakeholders, and customers.Should be familiar with cGMP or be able to quickly learn and apply cGMP principals and must be able to design safe work practices.Demonstrate a willingness to share skills and information with others.Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification.  Act ethically.Demonstrate a bias toward action.  Get things done.  Be willing to take a position, and assert influence to drive improvement.  Foster teamwork to get results.Demonstrated ability to read, write, and speak clear English.#URL_7e94b9dc45c2319c1dffe1d1646563b8cf079c66d210b9bb860f4f51783ffb03# 
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