Process Automation Engineer
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Process Automation Engineer executes automation design engineering activities for site capital and operational improvement projects within the Engineering team in Canton. This position requires participation in the concept development, design, fabrication, commissioning and qualification of process systems in a GMP environment. This position also partners with the Manufacturing Technology team in the development and / or technology transfer of new solutions and modifications to our existing manufacturing process systems while adhering to established regulatory compliance requirements. The incumbent is responsible for developing appropriate solutions to satisfy the needs of internal customers in accordance with company guidelines and procedures, and within project budget and schedule commitments.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Author, review and approve all technical documents throughout the equipment/system lifecycle from commissioning and qualification through decommissioning and retirement.
• Management and execution of automation projects. For a given project, developing scope, design, schedules, and budgets, along with conducting and coordinating technical reviews. Project values may range from $10K to $500K.
- Responsible for demonstrating skills in requirements gathering, design, configuration, integration and implementation of process control solutions for the manufacturing industry including batch software, PLC / DCS systems, HMI packages, SCADA systems, Visual Basic and PC networking technology.
- Responsible for the incorporation and satisfaction of user requirements and quality requirements within design solutions.
• Preparation of engineering standards, approval of submittals, and authoring PMs, SOPs, Commissioning Protocols, and conducting factory acceptance, site acceptance, on-site start up, commissioning, qualification and training for new equipment. May require travel for Factory Acceptance Testing.
• Responsible for the site Data Historians, Building Managements Systems, and site PLC based Process Control Systems.
• Complete investigations of process/automation system deviations and implement corrective and preventive actions as required to mitigate future recurrence.
- Manage relevant engineering activities and prioritize work to ensure site and project timelines are met. This will include direct assistance on the production floor.
- Management and execution of remediation projects. For a given project, developing scope, design, schedules, and budgets, along with conducting and coordinating technical reviews.
- Coordinates the efforts of engineering support groups and external resources such as vendors, consultants, and contractors. May be required to work with service providers and contractors while they are on-site performing maintenance, repairs and projects on systems and equipment.
- Provide engineering services operating systems and capital projects focusing on capacity increase, process optimization, risk mitigation, and compliance improvements
• May be called upon to speak to regulatory agencies regarding manufacturing systems and equipment as a subject matter expert.
• Liaise with Quality Assurance and Regulatory Affairs and prepare/review documentation required for regulatory submissions and change controls.
• Support the Engineering Drawing Management program.
• Provide relevant engineering support to the facilities team as requested.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Minimum B.S., Biochemical, Chemical, Mechanical or Electrical Engineering.
• 5 or more years of experience in applied process design engineering relating to biological production, strongly preferred.
• Extensive knowledge of GMP requirements and commissioning and qualification required.
• Possesses strong knowledge of regulatory requirements related to GMP, GAMP, CFR 210, 211, Part 11.
• Proven programming experience with PLC’s and HMI’s (including Allen-Bradley/Rockwell) and knowledge of process manufacturing field instrumentation.
• Well versed in typical process engineering documentation, such as Process Flow Diagrams (PFD’s), Piping and Instrumentation Diagrams (PID’s), User Requirement Specifications (URS), and Equipment Design Specifications.
• This position requires strong analytical skills (ability to apply engineering principles to design), hands-on troubleshooting skills and the capability to utilize AutoCAD, analysis software and company quality system software.
• Ability to effectively communicate, interact and collaborate with internal and external team members is essential.
• Proven experience with Building Management Systems and Process Historians.
• Must be able to critically evaluate data summaries and conclusions.
• Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
• Prior experience with SAP or another ERP/CMMS platform for Work Order and Calibration management is desirable.
• Quality Systems experience desirable.
• Experience in using SAP is an advantage.
• Must lead by example through strong work ethics and high standards.
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.