Process Engineer

Location
Canton, MA, US
Posted
Aug 28, 2020
Ref
671130400
Required Education
Bachelors Degree
Position Type
Full time
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 Engineer executes process design engineering activities for site capital and operational 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 is also a participant with the Manufacturing Science and Technology team in development and technology transfer of new solutions or 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 and external customers in accordance with company guidelines and procedures, and within project budget and schedule commitments.
This position will specifically support the build and operation a new CDMO facility in Canton, focused on implementation of new flexible technology and single use systems. Based upon demand, this position will flex to support ongoing ACAM2000 production as required.

Responsibilities
  • Author, review and approve all technical documents throughout the equipment/system lifecycle from commissioning and qualification through decommissioning and retirement.
  • Management and execution of process equipment acquisition 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.
  • Execution and documentation of commissioning, functional tests, protocols and qualifications for new systems. May require travel for Factory Acceptance Testing.
  • Responsible for the incorporation and satisfaction of user requirements and quality requirements within design solutions.
  • Complete investigations of process 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 general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

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. Formal training in bioreactors and/or typical separation and purification technology applications in biologicals manufacturing is an advantage.
  • Individual with experience must have knowledge of unit operations typically used in biotech and vaccine manufacturing such as bulk manufacturing, upstream and downstream operations, formulation, steaming (SIP) and cleaning (CIP).
  • 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.
  • Quality Systems experience desirable.
  • Must be able to critically evaluate data summaries and conclusions.
  • Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required
  • Experience in using SAP is an advantage.


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requires vaccination against different viruses including Vaccinia virus and Japanese Encephalitis virus.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

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.