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
I. JOB SUMMARY
The Sr. Process Engineer will lead technical engineering
expertise within multiple areas of responsibility including
engineering, validation, technology transfer and equipment/system
maintenance. Develops and recommends new technologies to achieve
cost effective and improved equipment/systems robustness. Develop
plans and strategy for new product introductions; and establishes
operating equipment specifications and improves manufacturing
techniques/processes. 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
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals
with disabilities to perform the essential functions.
- Lead one or more tech transfer / high impact Engineering
- Conduct, plan, and lead cross functional projects of one or
more processes into manufacturing
- Responsible for coordination of technical activities on
- Evaluate incoming processes for operability and develop risk
- Provide technical engineering oversight from development, to
the implementation and routine operation on process
- Develop documentation to support new equipment implementation
(User requirement specifications, Detail design specification,
Operating and Maintenance procedures, FAT, SAT, and commissioning
- Perform conceptual analysis of new project proposals;
feasibility analysis, scope of work, basis of design, project
schedule, budgetary estimate, facility utilization, risk analysis
and implementation plan.
- Implement engineering standards and best practices in the
design of projects, specification of instruments and equipment,
oversee/ coordinate the fabrication, installation and
implementation of solutions to process problems.
- Troubleshoot and aid in the repair of process equipment/systems
as required to maintain GMP standards for optimal performance.
Responsible for ongoing optimization and improvement in
equipment/systems/processes for long term robustness and
- Perform deviations/investigations/CAPAs/Change Control
write-up. Provide engineering studies, technical engineering
support, training and leadership to manufacturing, QA, validation,
Quality Control, Validation, Facilities, and Metrology for
continuous process improvement, troubleshooting, change control and
- Author, review and approve all technical documents throughout
the equipment/system lifecycle from commissioning and qualification
through decommissioning and retirement.
- Execution and documentation of functional tests, protocols and
qualifications for new systems.
- May be required to work with service providers and contractors
while they are on-site performing maintenance, repairs and projects
on buildings, systems and equipment.
- Interface with other departments and sites regarding special
projects and quality issues as required.
- May be called upon to speak to regulatory agencies regarding
manufacturing systems and equipment as a subject matter
- Liaise with Quality Assurance and Regulatory Affairs and
prepare/review documentation required for regulatory submissions
and change controls.
- In areas of health, safety and environmental policy: Provide
guidance, leadership and directives to support and comply with all
policies. Contribute toward meeting departmental goals and
demonstrate progress in preventing or reducing injuries.
- Requires vaccination against different viruses including
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
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelor's Degree in a science or engineering discipline or
equivalent with 8+ years of process experience, Master's degree
with 4+ years process experience, or PhD with 2+ years process
Experience with Receiving and Evaluating Technology Transfer
Data, Development of Bills of Materials, and Evaluation of GMP
Experience as a Project Lead
Strive for Results, Make Decisions, Lead Teams, Develop People,
Extensive knowledge of GMP requirements, formulation, parenteral
filling, inspection and packaging, commissioning and qualification
A self-motivating and goal-oriented individual with proven
technical engineering skills. Must have strong oral and written
skills with emphasis on technical writing for
This position requires strong analytical skills (ability to
apply engineering principles to design), hands-on troubleshooting
Quality Systems experience desirable.
Must be able to critically evaluate data summaries and
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
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
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
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
- 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