Associate Engineer II, Validation
Company: Emergent BioSolutions
Posted on: May 16, 2020
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
* JOB SUMMARY
The Validation Technician will to develop and execute validation
protocols with a focus on periodic re-qualifications and will
include support for new equipment/process qualifications
(IQ/OQ/PQ). This includes analyzing data and authoring
final/summary reports. This position will conduct investigations
for protocol non-conformances and implement corrective actions. The
position will interact with cross-functional teams to support
various projects that have a validation component such as
Operational Excellence (OE) initiatives, tracking and reporting key
performance indicators (KPIs), and reporting metrics to QA.
* ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with
disabilities to perform the essential functions.
* Write and execute validation protocols and reports, (IQ / OQ /
PQ), for the validation of new and existing processes and
* Write validation summary reports for executed protocols.
* Use Kaye Validator/temperature dataloggers, or equivalent, to
perform mapping studies.
* Analyze statistical data to verify acceptable criteria.
* Provide technical support/troubleshooting for process and
* Attend production and team meetings, as required.
* Maintain close contact with internal departments to assure
effective communication on issues related to validation.
* Apply CGMP guidelines to all aspects of validation.
* Investigate/resolve non-conformances and/or deviations associated
with validation studies.
* Author technical documents such as functional tests, engineering
studies, deviations, gap analyses, and risk assessments.
* Perform periodic reviews of equipment /systems as part of the
* Critically review data to ensure completeness, accuracy and
* Qualify change parts for fillers, cappers, vial washers, labeler,
cartoner, and serialization machines to support new products.
* Apply CGMP and CGDP to all areas of work.
* Requires vaccination against different viruses including Vaccinia
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
BS in Science or Engineering is preferred with a minimum of 2 years
relevant job experience, or an Associates Degree in a technical
discipline with a minimum of 8 years doing validation in the
* Strong organization and communication skills; high level of
self-accountability and responsibility.
* Ability to manage and coordinate multiple priorities and tasks in
a dynamic environment.
* Excellent written and verbal skills.
* Ability to exercise sound judgment to determine appropriate
* Ability to exercise judgment for following defined practices and
* Ability to exercise judgment when selecting methods and
techniques to solve problems.
* Ability to use computer programs such as Microsoft Suite, SAP,
* Good intrapersonal skills that enable working collaboratively and
effectively in a team environment.
* Proficient knowledge of CGMP.
* Ability to make sound decisions regarding compliance-related
issues with moderate supervision and guidance.
* Experience and knowledge of HVAC systems, clean rooms,
sterilization equipment, pharmaceutical water systems, computer
control systems, and aseptic manufacturing is very desirable.
* PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
The physical/mental demands are representative of those that must
be met by an individual to successfully perform the essential
functions of the job.
The work environment characteristics described here are
representative of those an individual would encounter while
performing the essential functions of the job.
Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.
Physical/Mental Demands and Work Environment Characteristics:
Ability to organize/coordinate Comprehend and follow
Direct, control and plan Independently make quick decisions to
solve complex issues
Problem Solve Analyze/Interpret data and information
Perform with frequent interruptions Make decisions using sound
Good eye/hand coordination Visual Acuity
Use keyboard/computer/phone Detect/Distinguish smell
Detect/Distinguish hearing Maintain stationary position
Position self to move Move/Traverse
Ascend/Descend (climb) Reaching
Calibrate precise Ability to safely operate hand tools
Move/Transport [X] lb. Repetitive movement activities
Regular and predictable attendance
Work around extreme temperatures cold or hot
Work around noise above conversation level
Work in restricted access to laboratory area
Exposure to dust/gas/fumes/steam/chemicals
Work with Select Agents as defined by the CDC
Work irregular hours that often include nights and weekends
Work in multiple locations
Minimal travel required. May include international travel.
Requires vaccination against different viruses including Vaccinia
Emergent BioSolutions is an Equal Opportunity/Affirmative Action
Employer and does not discriminate on the basis of race, color,
religion, gender, age, national origin, disability, Protected
Veteran status, sexual orientation, or any other characteristic
protected by 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 , Associate Engineer II, Validation, Engineering , Rockville, Maryland
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