Senior Project Engineer
Seymour Staffing is seeking a Senior Project Engineer for Automation to join the team at our client’s manufacturing facility in Daytona Beach, FL. Successful applicants will be responsible for functioning as a Project Engineer, individual contributor, architect and subject matter expert for Manufacturing Execution Systems and systems integration related to solutions manufacturing processes, related planning, testing and troubleshooting. Also, provide engineering expertise for the design, development, evaluation, implementation, startup, verification, maintenance, sustainability, and optimization of the Manufacturing Execution System. Also, demonstrate automation expertise within the engineering field while working across a variety of functional groups that are directly involved with capital project life cycles and site operations. 10 or more years of related experience and/or training in an applicable Manufacturing Execution System Type Engineering position in an engineering services and startup environment.
- Analyze existing Manufacturing Execution System to identify areas of improvement and recommend solutions to optimize.
- Identify, implement and lead data integrity methodologies for automated systems to ensure absolute reliability of the data being generated.
- Provide Manufacturing Execution System engineering support for manufacturing operations, and act as a liaison between manufacturing and Corporate IT and other business system stakeholders.
- Create and maintain MES configuration and Master Data to ensure the integrity of the data and guarantee GMP compliance.
- Ensure that the development, implementation, and delivery of MES training conforms to SOPs and are in compliance with cGMP.
- Ownership of automation system life cycle documents.
- Lead Recipe authoring.
- Author, edit and test Workflows and Master Batch Recipes (MBR) for new and existing products
- Lead integration of the Manufacturing Execution System with other automation systems.
- Develop detailed designs, implement and test PharmaSuite MES solutions that meet company manufacturing and regulatory requirements
- Refine and follow Business Process Maps and/or User Cases for configuration of execution workflows.
- Conduct data query and spreadsheet-based quantitative analyses; furnish data/reports to external and internal customers.
- Investigate and resolve system problems. Assist End Users with application and system issues. Review and analyze data, provide/recommend/escalate solutions.
- Provide emergency on-call support to MES production system users by phone or onsite 24 hours/7 days a week.
- Provide system integration support into the various SAP R/3/HANA modules within the company
- Gather, analyze and document business requirements; identify new areas of opportunity for SAP and MES functionality usage and recommend potential solutions.
- Promote strategies for efficiency improvements, lead/support implementation of organization process improvement initiatives and evaluate results.
- Define and document site standards collaborate with Engineering and Technology Management to institutionalize standards.
- Draft, edit and update SOPs as necessary to respond to resolution plans to support new automation, controls and instrumentation.
- Collect data, provide analysis and proactively identify variances to forecast to assist in developing strategies to improve performance and reduce cost.
- May be involved in forecasting and analyzing budgets and monitoring of expenditures versus budget, ensuring that expenses are charged to the appropriate cost center for accurate reporting purposes.
- Assist with training and auditing as appropriate.
- Supervise and direct contract personnel and outside vendors in the performance of contracted services.
- Provide leadership and collaborate with peers within the Engineering organization.
- Assist peers with requirements on projects that interface with Manufacturing Execution System.
- Support the shop floor production areas in regard to MES availability, user authorization, and security, downtime; system and application updates; problem reporting, troubleshooting, and escalation.
- Provide technical recommendations for management involving capital asset purchases and expenses for projects and/or strategic initiatives involving up to $5MM (capital/expense/revenue potentials).
- Prepare and present technical investigative reports to capital project leadership.
- Moderate to high degree of both internal and external personnel interfaces.
- Supporting/contributing role for other engineering functions.
- Must have strong problem solving and analytical skills with the ability to produce results with minimal supervision.
- Must be a team player, detail oriented and be able to function effectively in a cross-functional team environment.
- Perform other duties as assigned.
Knowledge and Skills
- Strong aptitude for design, planning, testing, troubleshooting, Manufacturing Execution Systems.
- Ability to prepare system user requirements necessary to achieve integrated solutions and GMP regulatory compliance, and to function sustainably in a qualified state.
- Knowledge of product/process requirements including regulatory, design, operational and performance.
- Expertise in the development of functional requirements for MES solutions through project requirements, operations, and quality interviews as well as documentation analysis
- Ability to prepare functional specifications and design specifications that meet defined system requirements for applicable systems.
- Working knowledge of automation system requirements, function and software design.
- Experience with FactoryTalk Production Centre, PharmaSuite, LabWare LIMS, and PI-Historian.
- Extensive knowledge and implementation experience of ANSI/ISA-88 and ANSI/ISA-95
- Experience integrating ANSI/ISA-88 and ANSI/ISA-95 standards where the MES is integrated into the Batch
- Execution System (BES)
- Working knowledge ERP and Quality Systems integration.
- Experience with PLC interface and communication over OPC.
- Experience with .NET technologies.
- Knowledge of SAP/SAP 3rd Party Applications, Windows, Relational Databases, SQL, Oracle, MS Office Professional, MS Visio, MS Project, Lotus Notes, business process analysis, workflow process and design methodology.
- Use of standard operating systems; network environments and application software.
- Working knowledge of Federal Food and Drug Administration (FDA), OSHA and Good Manufacturing Practices (GMP) requirements.
- Use a broad range of software used in the Pharmaceutical industry (e.g. MS Office applications, MS Project, MS Visio, AutoCAD, SAP, etc.).
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Strong communication skills, both verbal and written, commensurable with dealing with senior level management.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Work independently and as a team member.
- Bachelor's Degree in Electrical/Electronics Engineering
- 10 or more years of related experience and/or training in an applicable Manufacturing Execution System type Engineering position in an engineering services and startup environment.
- Deployment experience with plant floor/Manufacturing Execution Systems (MES) solutions (e.g. Rockwell ProPack Data, Werum PAS-X, POMS)
- Experience in at least one computer language.
- Experience and/or advanced training in administrating 3rd party applications or database systems in a Windows operating system environment.
- Domestic and International travel as necessary.
- May be required to work or be assigned to a different shift as needed.
- Related engineering experience and training in a Life Sciences manufacturing environment.
- Knowledge of FDA, EU, and global GMP’s including Good Automated Manufacturing Practices, 21 CFR Part 11, and EU cGMP Annex 11. Knowledge of Data Integrity Requirements for FDA, EU, and global regulatory authorities.
- Knowledge of SAP Material Master (MM), Production Planning (PP), Production Planning for the Process Industry (PP/PI) and Quality Management (QM) modules.
- Knowledge or exposure to Software Development Life Cycle methodologies and formal Change Management practices.
- Relevant Quality education or training within ISO 9001 and cGMP.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
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Seymour Staffing Mission Statement:
A company is only as good as its people. It is important to remember as the company grows, its greatest asset should grow and benefit as well. When a company has a truly great employee, that employee carries deep institutional value and knowledge that simply cannot be replaced. At the end of the day, it's not the product, service or technology that makes your company succeed, it will be great people helping your company to not only succeed, but to flourish. Seymour Staffing constantly strives for excellence by working hard to achieve our goals and encourage our staff to be honest and to honor their commitments. We believe that integrity and hard work will help us meet our commitments to our clients.
Seymour Staffing is an equal opportunity employer.