Sr Process 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 Senior Process Engineer executes process design engineering activities for site capital and operational improvement projects within the Engineering team at Canton, MA site. The Senior Process Engineer will execute large concept development, design, fabrication and commissioning activities for process systems in a GMP environment. This position is also a participant 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.
o Oversite and execution of capital and process improvement projects from inception to turnover to user groups.
o Management and execution of 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.
o Author, review and approve technical equipment/system lifecycle documents, such as User Requirement Specification (URS), Design Specifications and Operating Procedures.
o Responsible for the incorporation and satisfaction of user requirements and quality requirements within design solutions.
o Preparation of design packages and specifications, RFP’s, design review, vendor/contractor selection, constructability reviews, approval of submittal, and authoring of change controls.
o Support site CQV team in qualification and validation activities
o Complete investigations of process system deviations and implement corrective and preventive actions as required to mitigate future recurrence.
o Manage relevant engineering activities and prioritize work to ensure site and project timelines are met. This will include direct assistance on the production floor.
o Assists in programming, maintenance and troubleshooting of programmable logic controllers and process and building monitoring systems
o Develop Engineering drawings, such as layouts, P&ID’s and PFD’s. Support the Engineering Drawing Management program.
o Reputation as emerging leader in the field with sustained performance and accomplishments
o Interface with other departments and sites regarding special projects and quality issues, demonstrating technical proficiency, scientific creativity and collaboration
o May be called upon to speak to regulatory agencies regarding manufacturing systems and equipment as a subject matter expert.
o Liaise with Quality Assurance and Regulatory Affairs and prepare/review documentation required for regulatory submissions and change controls.
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
o Minimum B.S., Chemical, Mechanical or Biochemical Engineering.
o 8 or more years of experience in applied process design engineering relating to biological production.
o 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.
o Individual with experience must have knowledge of unit operations typically used in biotech and vaccine manufacturing such as bulk manufacturing, downstream operations, formulation, steaming (SIP) and cleaning (CIP).
o 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.
o Proven programming experience with PLC’s and HMI’s (including Allen-Bradley/Rockwell) and knowledge of process manufacturing field instrumentation
o Experience with Building Management Systems and/or Process Historians is an advantage.
o Ability to effectively communicate, interact and collaborate with internal and external team members is essential.
o 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.
o Strong communication and computer skills
o Experience processing and managing quality deviations, CAPA, EC’s, and change controls.
o Must be able to critically evaluate data summaries and conclusions.
o Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required
o Experience in with a ERP/CMMS platform, such as SAP, is an advantage.
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.