Quality Engineer

Profile

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
The Quality Engineer is responsible for supporting Engineering and Facilities compliance related to direct and indirect critical utilities, process systems, and procedures in support of day-to-day activities. A broad scope of technical knowledge and regulatory knowledge is required to analyze risk, support internal and external quality systems, audits, and plant compliance. This is a hybrid role, with part time remote capability.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Deviations: initiate investigations, perform root cause analysis, assess impact, and implement durable corrective and preventive actions to prevent future deviating events.
CAPA System: utilize quality systems to identify and implement continuous improvement, corrective, and preventive actions for system level improvements.
Change Control System: the ability to identify and initiate changes through collaborative efforts with Quality Assurance and various departments in response to deviations, CAPA's and departmental continuous improvement projects.
Represent the department in interactions with internal functional units and external contract partners or regulatory officials.
Department procedures: create, revise, and maintain Standard Operating Procedures, work instructions, and Preventive Maintenance and Calibration tasks.
Critically review various types of documentation to ensure completeness, accuracy, and compliance.
Lead and participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product.
Plan, prepare, schedule, and participate in internal and external quality system audits related to Engineering and Facilities. This includes reviewing prior internal audits and regulatory inspections, procedures, processes, and activities related to facility audit preparedness.
Drive inspection readiness strategy and activities and serve as a subject matter expert in quality systems related to Engineering and Facilities.
Prepare functional and management review metrics for identification of negative trends and present to Management team. Conduct analysis of identified negative trends, propose and implement necessary corrective actions.
Frequently interact with direct manager, peers, internal customers, external clients, and other cross functional peers across Emergent to gain alignment on quality decisions.
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
Required
Bachelor's Degree in Engineering or related fields
A minimum of five (5) years of cGMP compliance experience
Experienced with US pharmaceutical regulations, ISO standards
Knowledge and application of cGMP principles
Excellent technical writing skills
Excellent facilitation and presentation skills
Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability, decision making, coaching
Interpersonal skills: team building, consensus building, conflict resolution
Critical analytical skills, strong verbal and communication skills
Must be able to critically evaluate data summaries and conclusions
Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
Ability to influence without authority across cross-functional organization
Preferred
SAP experience
Quality Auditor, Six Sigma, or equivalent certification/education
Experienced with EU and Canadian pharmaceutical regulations
Expert Knowledge and application of cGMP principles
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 .
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.
Category
Industrial Engineers
Education
Bachelor's Degree
Experience
5 years
Job type
Part time
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