Process Engineer III, Manufacturing Tech

Location: 

Canton, MA, US, 02021


 

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 III MSAT will lead development and manufacturing-related projects. The incumbent will prep, coordinate, execute, and summarize study plans/protocols.  

 

The incumbent should have a solid education, strong technical skills, and deep cGMP experience to support the MSAT missions, i.e., ensure that manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved.
    
ESSENTIAL FUNCTIONS

The MSAT department at the Canton site of Emergent BioSolutions ensures that manufacturing processes are capable, compliant, in control, cost-effective, and continuously improved. Our core responsibilities include: 
•    Enable reliable supply of vaccines and therapeutics by providing scientific and technical leadership to commercial manufacturing operations.
•    Anticipate, respond to, and permanently resolve manufacturing issues to safeguard our right to operate and supply.
•    Support new processes, equipment, facility design, and other life-cycle activities to improve quality, efficiency, capacity, and economics.

Business

•    Work independently with minimal direction and supervision
•    Maintain good working relationships with internal and external partners/customers, i.e., Manufacturing, QA, QC, Regulatory, Engineering, Supply Chain, EHS, etc.
•    System owner responsibilities for multiple focus areas within the MSAT function, e.g., Process Monitoring, Process Validation, Technology Transfer, Continued Process Verification, etc.
•    Contribute to the completion of milestones associated with specific projects. 
•    Primarily internal company contacts. Infrequent inter-organizational and outside customer contacts.
•    Apply cGMP, cGLP, and cGDP to all areas of work.

Technical 

•    Provide fast-paced campaign support for manufacturing during technical production issues or escalations
•    Work with manufacturing teams to provide technical support to manufacturing to develop platform procedures, batch records, training, and other manufacturing resources as required to prepare for and execute processes.
•    Write and revise SOPs and Master Plans periodically or as part of process improvements.
•    Support existing business processes such as reviewing MFG SOP/FRM/BPR document revisions, deviations, CAPAs, CCRs.
•    Develop and maintain structure for process data reviews for internal and external production
•    Develop and draft study plans and protocols as required to support regulatory requirements, deviations response, process changes, etc.
•    Lead process investigations and drive process improvement initiatives.

People Management/Employee Development

•    Supervise daily activities for Intern/Co-op students and contractors to ensure safety and effectiveness
•    Assist Manager in bringing new staff up to speed. Train new employees or junior staff on hands-on skills 

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
•    BS, MS, or PhD in Science or Engineering with a minimum of (BS+6 yrs) /(MS+4yrs)/ (PhD+2yrs) of relevant job experience in biopharma or pharmaceutical industry
•    The Process Engineer III should have solid technical leadership in several functional areas, as well as cGMP experience with vaccines/biologics manufacturing science and technology.
•    Ability to manage multiple priorities and tasks in a dynamic environment. 
•    Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability
•    Work effectively in a team environment and have a high level of personal accountability and responsibility.
•    Understanding of MSAT activities including but not limited to: Technology Transfer Strategy and Implementation; Process Development, Product Process Improvement, QbD / PAT; Process Characterization and Control; Process validation
•    Comprehensive technical knowledge with a strong science-and-risk based mindset
•    Good technical and communication skills: oral/written and listening
•    Proficient in Microsoft Office and Electronic Document Management System.

Preferred Qualifications

•    Ability to manage multiple priorities and tasks in a dynamic environment. 
•    Ability to make sound recommendations regarding quality-related issues with some supervision and guidance.
•    Personal Competencies: Self-awareness, Integrity, Team Player, Adaptability
•    A solid technical background across various scientific disciplines, including manufacturing process technol

 

Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment,  subject to legally required exemptions.

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.
 

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Boston