|Date Posted||June 21, 2022|
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 Sr Automation Engineer is responsible for designing, managing, troubleshooting, and maintaining a variety of automation platforms that are used to monitor and control process and utility equipment, and engineering and facility systems at the Emergent BioSolutions GMP production facility in Canton, MA. This individual will need to manage multiple projects of varying complexity and size and will be required to manage outside control system integrators. The Sr Automation Engineer will be required to interface with representatives from internal groups, including Manufacturing, Validation and Quality, and to enter the gowned clean room production areas as required for assignments.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Possesses expertise in automation engineering practices and applies these skills to perform a wide variety of troubleshooting and maintenance activities on site equipment and systems.
• Responsible for the site Data Historians, Building Managements Systems, and the site PLC based Process Control Systems.
• Preparation of design packages and specifications, functional specifications related to software and hardware RFPs, design review, vendor/contractor selection, constructability reviews, approval of submittals, and preparation and oversight of validation and regulatory submissions.
• Possesses strong knowledge of computer system validation and related practices, including GMP and 21 CFR Part11 requirements.
• 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.
• Preparation of engineering standards, approval of submittals, and authoring PMs, SOPs, Commissioning Protocols, and conducting on-site start up and training for new equipment.
• Coordinates the efforts of engineering support groups and external resources such as vendors, consultants, and contractors
• Provide process control engineering services for legacy systems and for capital projects focusing on capacity increase, process optimization, risk mitigation, and compliance improvements
• Creates project cost estimates, budgets and schedules and monitors for compliance.
• Author, review, and approve automation system lifecycle design documentation (user requirements, functional and design specifications, system integration, commissioning, and qualification protocols)
• Must have knowledge of process manufacturing field instrumentation, metrology practices, and automated calibration management platforms.
• Able to author and manages complex Change Control plans and documents.
• Able to complete investigations of complex deviations and to implement corrective and preventative actions (CAPA's) as required to mitigate future recurrence.
• Skilled in root cause analysis and risk assessment processes.
• Responsible for working well within teams and in leading meetings with the customer, other project stakeholders, and external consultants during all phases of a project.
• Demonstrates strong leadership qualities and can provide technical direction to other engineers.
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
• Bachelor's Degree in Electrical, Mechanical or Chemical Engineering from an accredited university.
• Minimum of 8 years of automation industry experience.
• Minimum of 5 years of experience in an GMP pharmaceutical environment.
• Proven programming experience with PLC's and HMI's (including Allen-Bradley/Rockwell) and knowledge of process manufacturing field instrumentation.
• Proven experience with Building Management Systems and Process Historians.
• Prior experience with SAP or another ERP/CMMS platform for Work Order and Calibration management.
• Expert knowledge of engineering principles and concepts.
• Extensive knowledge of GMP requirements as well as commissioning and qualification practices in a pharmaceutical environment.
• Possesses strong knowledge of regulatory requirements related to GMP, GAMP, CFR 210, 211, Part 11
• Strong communication and computer skills.
• Must lead by example through strong work ethics and high standards.
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.