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Associate Engineer II, Validation

Company: Emergent BioSolutions
Location: Rockville
Posted on: May 16, 2020

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.

* 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 equipment.

* 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 equipment issues.

* 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 periodic revalidations.

* Critically review data to ensure completeness, accuracy and compliance.

* 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 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 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 pharmaceutical industry.



* 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 corrective actions.

* Ability to exercise judgment for following defined practices and policies.

* Ability to exercise judgment when selecting methods and techniques to solve problems.

* Ability to use computer programs such as Microsoft Suite, SAP, and EDMS.

* 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:



Mental Demands:

Ability to organize/coordinate Comprehend and follow instructions



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 judgment



Supervise/Manage others



Physical Demands:

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

measurements



Move/Transport [X] lb. Repetitive movement activities



Environmental Characteristics:



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



Travel:



Minimal travel required. May include international travel.



Other Requirements:



Requires vaccination against different viruses including Vaccinia virus.





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 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 , Associate Engineer II, Validation, Engineering , Rockville, Maryland

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