BioProcess Associate
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 This role provides foundational HR
process & program support, and supports client groups by applying
HR solutions from a defined set of alternatives, including but not
limited to the following areas: organizational and structure
changes, employee relations issue management, talent management,
leadership coaching, performance management, HRIS systems,
reporting and other business needs as required. I. JOB SUMMARY The
associate in this position is expected to possess a clear
understanding of the fill finish operations. This position involves
aseptic fill operations using isolator technology, visual
inspection, labeling, and packaging as per GMP regulations. The
candidate will also be interacting with cross-functional
departments to troubleshoot, request materials, and to overcome
challenges in meeting the production schedule. Previous experience
in cGMP is required. II. ESSENTIAL FUNCTIONS Reasonable
accommodations will be made to enable individuals with disabilities
to perform the essential functions. --- Execute daily tasks such as
washing and sterilizing vials and filling components for use in
production operations. Perform area clearance on equipment and
rooms that involve cleaning, and integrity testing pre/post
production. --- Perform Aseptic filling operations and dynamic
monitoring/sampling inside various isolators. --- Adhere to
Standard Operating Procedures (SOP), Good Documentation Practices
(GDP), and current Good Manufacturing Practices (cGMP). --- Record
Activities in production batch records, and equipment logbooks as
well as updating and/or authoring SOPs. --- Review documentations
and check all calculations. --- Maintain an inventory of
manufacturing supplies and order additional materials as necessary.
--- Assist in activities related to other onsite departments such
as the execution of validation protocols. --- Comply with all
applicable health, safety and environmental policies promoting a
safe workplace to prevent or reduce injuries. --- Perform tasks
under minimal supervision, and within tight time lines to meet
production schedule. --- Report any unexpected observations and
suggest possible explanation and resolution. 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 --- BS/BA in Biology,
Chemistry, or related discipline --- 2-4 years' experience in a GMP
facility or High School Diploma and at least 4 years' experience in
a GMP facility. --- Good interpersonal skills and attention to
detail. --- Previous experience working with aseptic technique and
good documentation practices preferred. --- Must be able to follow
cGMP regulations during operations including adherence to written
procedure and contemporaneous documentation. --- Must be able to
record data accurately and legibly. --- Demonstrated mechanical
aptitude. --- Ability to perform in a team setting in a controlled
environment for long periods of time. 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 , BioProcess Associate, Other , Rockville, Maryland
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