- Lead Manufacturing Engineer on capital projects – overall project management, budget, schedule management, construction management, start-up, conceptual phases, project close-out, scope development, cost estimation, system design, equipment sizing and selection, procurement, installation, check-out, and validation (IQ/OQ & PQ).
- Lead system design standards development for divisional unit operations. Includes improvements to existing standards using appropriate technical evaluation and involvement.
- Maintain engineering interface with business unit team – develop and maintain close working relationships with Research & Development, Quality, Manufacturing, Manufacturing Leadership, and Financial Operations.
- Offer production support and troubleshooting assistance to Engineers, Production Staff, and Maintenance.
- Provide innovative technical solutions required to meet business objectives with emphasis on productivity.
- Provide support to capital planning process, new product development, and process automation.
- Perform validation of equipment, automation systems, data collection systems, and processes for the manufacturing operations.
- Preparing protocols, performing testing, collecting samples, analyzing test results, and preparing summaries.
- This position will coordinate the activities of Engineering, Manufacturing, Quality, and other Company groups required to complete assigned equipment projects in support of the operation of the manufacturing facility. (design, construction, start-up and commissioning)
- Support/manage the activities of assigned junior and contract personnel and ensure the quality of completed work.
- Provide technical assessment and validation review/approval for engineering and process changes.
- Investigate and close Problem Reports (PRs) and Non-Conformance Reports (NCRs) in a timely and effective manner. Implement Corrective and Preventive Action (CAPA) as appropriate.
- Utilize Lean Manufacturing Tools such as Root Cause Analysis, Gemba and Poka-Yoke to continually improve manufacturing operations.
- The Manufacturing Engineer III will manage and/or apply extensive technical selection and validation engineering expertise in the coordination of multiple, complex, non-routine projects involving the planning, design, reconfiguration, construction, and alteration of processes, systems or equipment.
- Specific responsibilities include applying advanced technical principles, theories, and concepts in the development of new principles and concepts, performing work that involves in-depth investigation of subject area.
- This position will independently provide and direct technical validation engineering support for process and/or equipment upgrades, replacements, and modifications in manufacturing and manufacturing support environments.
- Requires the ability to troubleshoot systemic validation issues, develop, organize, analyze, and present interpretation of results regarding operational issues or validation projects, and apply advanced validation engineering principles to the design and implementation of new or modified system or processes.
- Requires working knowledge of validation engineering principles and practices that can be applied to a broad variety of assignments in related fields, the ability to develop and apply creative technical solutions to complex problems, and working with manufacturing, process development, engineering, analytical, and quality assurance staff to develop validation requirements and recommendations for large and/or highly complex processes and systems.
Minimum Qualifications (must have)
- BS/BA degree in Chemical or Mechanical Engineering or related industry experience.
- A minimum of 7 years of equipment selection experience in a cGMP environment with increasing levels of responsibility for a wide range of projects, including design, validation, and operation of large scale manufacturing, and automation systems.
- Must be able to work independently as well as with teams, organize and manage projects by defining milestones, budgets and schedules; prepare regulatory summaries and present validation to regulatory authorities.
- Must have a thorough knowledge of validation principles, manufacturing processes, quality systems, engineering design and start-up fundamentals, regulatory agency expectations and industry trends.
- Experience with regulated environments (i.e. cGMP, FDA, ISO 13485, OSHA, EPA) is essential.
- Candidates should have experience in pharmaceutical/biotech processes, and familiarity with documentation in a highly regulated environment.
- Ability to apply validation engineering to production and develop solutions to routine technical problems of varying complexity and scope.
- Requires strong technical writing, mechanical aptitude, verbal communication, and interpersonal and problem solving skills.
- Experience relative to govern / regulated products, equipment, and control systems.
The position may require travel (up to 20%) during the duration of projects for vendor/contactor meeting and FAT execution.
This position has not been approved for Relocation Assistance.
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