Manager, Process Engineer
Company: Emergent BioSolutions
Location: Rockville
Posted on: May 15, 2022
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Job Description:
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 Individual will provide technical
engineering expertise within multiple areas of responsibility
including engineering, validation and equipment/system maintenance.
Develops and recommends new technologies to achieve cost effective
and improved equipment/systems robustness. Develops plans and
strategy for new product introductions. Establishes operating
equipment specifications and improves manufacturing
techniques/processes. Plans and delivers capital projects.
Supervises direct reports. II: Responsibilities (Include key
responsibilities only. This should not be an all-encompassing list)
--- Provide technical engineering oversight from development, to
the implementation and routine operation on process
equipment/systems. --- Develop documentation to support new
equipment implementation (User requirement specifications, Detail
design specification, Operating and Maintenance procedures, FAT,
SAT, and commissioning documents). --- Perform conceptual analysis
for new capital 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 reliability. --- 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 deviation
resolution. --- 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.
--- Manage contract engineers, and engineering service providers
depending on the current projects and workloads. --- 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). 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. III: Education, Experience & Skills Minimum of Bachelors
degree in engineering (chemical, industrial, mechanical, or related
discipline) Minimum 7 years of engineering experience in the field
of pharmaceutical/biotechnology (or equivalent). Strive for
Results, Make Decisions, Lead Teams, Develop People, Think
Strategically. Supervises and manages direct reports in a manner
that encourages collaboration and personnel development.
Exemplifies leadership, integrity, and fosters the company core
values. Enforces disciplinary actions as needed. 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 deviations/investigations/CAPAs. 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. 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.
Keywords: Emergent BioSolutions, Rockville , Manager, Process Engineer, Engineering , Rockville, Maryland
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