Sr Engineer, MS&T
Company: Emergent Biosolutions
Posted on: January 22, 2023
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 candidate will lead process validation activities and
manufacturing process transfer as a member of the Technical
Transfer Process Team which is a part of the Manufacturing Science
& Technology (MS&T) Department supporting the contract
manufacturing business unit. The candidate will primarily be
responsible for leading one or more technical transfer projects for
the aseptic fill and finish of pharmaceutical and biological drug
products. Responsibilities include leading project teams, designing
experiments/studies, authoring protocols (e.g., engineering runs;
process performance qualifications), reviewing and analyzing
complex data, and authoring process validation protocols and
reports. Candidate will support the development of manufacturing
production records and coordinate process specific training with
manufacturing and laboratory personnel.
Previous expertise with contract manufacturing, technology
transfer, fill/finish operations, aseptic and/or isolator
manufacturing, process validation/process performance
qualifications, and technical writing are critical to this role.
Candidate must also have excellent communication skills, both
written and verbal.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with
disabilities to perform the essential functions.
Lead one or more technology transfer project teams including, but
not limited to:
- Conduct, plan, and lead technology transfer of manufacturing
- Coordinate technical activity associated with assigned projects
(e.g. completion of new equipment validation, material procurement
and implementation, etc.).
- Collaborate with analytical, production, quality and project
management team and ensure timely completion of project
- Evaluate incoming processes for operability and lead process
and facility risk assessment activities.
- Work with project management and external groups to support
technology transfer activities.
- Author and review technology transfer and manufacturing
documents including plans and reports.
- Act as key technical lead for process development.
Independently design and manage studies for process development,
process optimization, scale-up, manufacturing records and
- Independently design studies for evaluating the robustness of
the manufacturing process. These studies will serve as a baseline
for the further process validation activities.
- Independently evaluate process data and perform in-depth
analysis using scientific principles for evaluation of critical
process parameters governing the performance of the process.
Exercises judgement in selecting methods, techniques and evaluation
- Represents MS&T department as subject matter expert
routinely in meetings/conference calls with clients
- Works with client's lead technical staff, department management
and senior management to evaluate complex technical details
pertaining to the project and defines the scope of the
- Makes recommendations to the business development team
regarding project studies and assist in preparation of project
- Function as the Subject Matter Expert (SME) for Manufacturing
processes and Technical Transfer of new products regarding process
- Independently review and analyze complex process data from the
clinical and commercial manufacturing batches for conformity and
facilitate batch release.
- Works independently and provide guidance to lower-level
personnel or as a team member.
- Execute Quality by Design experiments to support the
development and characterization of new manufacturing
- Independently manage multiple cross-functional projects that
may require regulatory submissions.
- Effectively present complex technical information to guide
- Independently author technical documents such as protocols,
reports, deviations, gap analyses, risk assessments, etc.
- Provide technical support for fill finish manufacturing
activities including OOS/OOT investigation, process deviation
impact, root cause investigation, process change and
- Perform periodic review of processes/systems.
- Write and revise SOPs and Master Plans, as necessary.
- Apply CGMP and CGDP to all areas of work.
- Provide training to production/laboratory staff for protocol
requirements and new manufacturing processes.
- Work with individuals at all education/experience levels and
with multiple departments (production, laboratory, engineering,
materials management, etc.)
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
- B.S. in Science or Engineering discipline with a minimum of 8
years of related job experience. M.S. in Science or Engineering
discipline with a minimum of 5 years of related job experience. PhD
in Science or Engineering discipline with a minimum of 3 years of
related job experience.
- Strong leadership skills; high level of personal/departmental
accountability and responsibility.
- Strong understanding of process design principles.
- Experience with drug product manufacturing processes transfer,
development, process scale-up and optimization.
- 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
- Excellent written and communication skills.
- Data evaluation and interpretation, including statistics and
- Experience and knowledge of sterile processing principles
(aseptic or isolator technology).
- Training and experience working in a BSL-2 facility is a
- Ability to exercise judgment to determine appropriate
- Ability to exercise judgment for defined practices and policies
in selecting methods and techniques for obtaining
- Ability to work in a team environment with multiple departments
and experience/educational levels.
- Proficient knowledge of CGMP.
- Regulatory background in pharmaceutical development/research is
Requires vaccination against different viruses including Vaccinia
Per CDC guidelines, Emergent strongly recommends that all employees
working on site are vaccinated to help ensure their safety, as well
as the safety of fellow employees. This includes the use of good
judgment when determining when the CDC guidelines advise that you
stay home when ill.
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
Keywords: Emergent Biosolutions, Rockville , Sr Engineer, MS&T, Engineering , Rockville, Maryland
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