Project Engineer

Location: 

Rockville, MD, US, 20850


 

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.

I. JOB SUMMARY
The Project Engineer will support both new capital projects and process improvement projects
related to current processes. This includes technical writing of specifications such as User
Requirement Specifications (URS), change controls, risk assessments, procurement related
documentation, and technical reports. This role will also be directly involved in project
execution from a hands-on perspective. For example, executing engineering runs and
feasibility studies. The Project Engineer will support multiple projects concurrently and requires
strong organizational and communication skills.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to
perform the essential functions.
• Design experiments/studies for engineering runs, feasibility studies, process
development, process optimization, and batch scale-up.
• Develop cost estimates, schedules, and project plans for capital projects.
• Act as technical point of contact for related projects.
• Independently evaluate proposals and quotes for process equipment, construction
services, and engineering services. Exercise judgement when recommending the
selection of these goods and services.
• Work with contractors, client representatives, and senior management to evaluate
technical details and logistics of projects to define the scope and schedule for the
project.
• Develop and maintain a site schedule of routine activities as well as special projects so
that projects can be completed timely and at appropriate times when production
activities permit.
• Collaborate cross-functionally with internal departments both locally and across the
Emergent network.
• Draft Request for Proposals (RFP) to solicit bids for equipment, engineering services
and validation services.
• Develop Statements of Work (SOW) that can be used to solicit bids from trades for
facility related projects. This includes technical descriptions as well as schematics
drawings to depict the plans.
• Independently manage multiple projects.
• Effectively present complex technical information to guide decision making.
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• Independently author technical documents that support quality assessments to include
gap analyses, and risk assessments.
• Perform investigations that support root cause identification of non-conformances and
deviations and develop and implement corrective/preventive (CAPA) actions.
• Provide technical support for fill finish manufacturing operations.
• Write and revise SOPs and Master Plans.
• Apply CGMP and CGDP to all areas of work.
• Requires vaccination against different viruses including Vaccinia virus.
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
B.S. in an Engineering discipline with a minimum of 5 years of equivalent job experience.
• Previous experience with fill/finish operations, capital projects, validation, and
technical writing are critical to this role.
• Excellent communication skills, both written and verbal.
• Strong leadership skills; high level of personal/departmental accountability and
responsibility.
• Experience with drug product manufacturing processes, process scale-up and
optimization.
• Experience with SCADA, DCC, and other automation system is very desirable.
• Ability to perform well under tight timelines and excellent decision-making quality
under pressure is desired.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Experience and knowledge of sterile processing preferred.
• Ability to exercise judgment to determine appropriate corrective actions.
• Ability to work in a team environment.
• Proficient knowledge of CGMP.

 

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: Washington DC