Quality Engineer Biotechnology
Quality Engineer Biotechnology
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1 Vacancy
Job Description
Essential functionsessential functions including how an individual is to perform them and the frequency with which the tasks are performed; the tasks must be part of the job function and truly necessary or required to perform the job.
Job duties to include but are not limited to;
- Work cross functionally with Science and Technology Manufacturing Engineering and Production in providing effective and responsive support to resolve inhouse customer and supplier quality related issues.
- Perform Corrective and Preventive action management with root cause analysis in order to safeguard the product and the customer experience.
- Assist in the development implementation and maintenance of the QMS to ISO9001 including completion of Internal Audits and development of internal processes/procedures.
- Perform inprocess and final assembly inspections collect and publish results and conduct feedback sessions for corrective and preventative action.
- Support the engineering and manufacturing teams to help design and execute the necessary product qualification and validation tests and any necessary analysis and followup activities.
- Participate in the development and improvement of the manufacturing processes for existing and new products. Coordination of Production Part Approval Process (PPAP) activities.
- Conduct product performance analysis and reporting.
- Drive and implement quality system improvements in alignment with and/or under the direction of the Quality Manager.
- Lead and participate in problem solving meetings using approved/formal problemsolving tools (8D PDCA etc).
- Maintain 5S practices. Participate / facilitate in LEAN 6 Sigma events.
- Support key quality and management system processes such as NCR CAPA and ECN.
- Lead training activities on Quality related procedures.
- Provide functional expertise to other support functions on quality related issues.
Qualifications :
Education/training:
Bachelors degree in Biology or other related Science discipline required. Engineering degrees considered. Significant relevant experience considered in lieu of a degree.
- ASQCertified Quality Auditor preferred.
- CQECertified Quality Engineer preferred.
- Lean six sigma green belt certified preferred.
- Statistical process control experience preferred.
Experience:
35 years minimum experience in a wet lab or pharmaceutical manufacturing environment required
- 3 years minimum experience in a quality engineer/assurance role
- Experience in cell culture including working with adherent and nonadherent mammalian cells preparing master and working banks and experience with cryopreservation techniques is preferred
- Experience or knowledge of working in a cGMP manufacturing facility.
- Experience working in a BSL2 facility.
- Strong capabilities in quality planning and analysis statistical tools and data analysis
- Experience with and good knowledge of ISO 9001
Knowledge/skills:
- Excellent oral and written communications.
- Strong analytical approach ability to facilitate team process problem solving with strong interpersonal skills.
- Fluent with MS Office
- Experience with management system implementation process mapping and flowcharting.
- Collaboration & Influencing the ability to engage challenge and work effectively with others
- Driving Change Willing and able to identify and support change and continuous improvement
- Must be able to work with minimal supervision
Background:
This position may require Sensitive Security Information (SSI) access and vetting via the TSA. If required applicant must successfully pass a federal background investigation. This position may require a U.S. Personal Security Clearance.
SDI is a Federal Contractor and a drugfree workplace. By submitting an application I confirm that I understand that the Company has a right to require me to submit to a drug test prior to employment and at any time during my employment to the extent permitted by law.
WORK ENVIRONMENT: The individuals primary workplace is located in the Baltimore MD biotechnology manufacturing facility; there are no exposures to unusual elements; possible exposure to biohazardous agents in BSL2 laboratory
Additional Information :
We offer
Join us and well help build your career with excellent training and opportunities for career growth across the business both locally and globally. Youll experience an inclusive environment with strong leadership and a focus on safety and wellbeing. Youll also have the flexibility to choose from a wide range of benefits to suit your lifestyle offering you and your family support from a health and wellbeing financial and lifestyle perspective.
Join us and work for a worldleader with the benefits and training to reward your dedication and skills. Be part of a team where we are making the world a safer place.
Smiths Detection is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity Posters If youd like to view a copy of the companys affirmative action plan or policy statement please email .
The compensation for this position ranges from $45760.00 $155200.00/yr and will vary depending on factors such as your location skills jobrelated knowledge and experience. The compensation package may also include incentive compensation opportunities in the form of discretionary annual bonus or commissions. Smiths Detection provides comprehensive benefits including healthcare 401K savings plan company holidays vacation sick time parental leave and an employee assistance program. Eligibility requirements apply.
If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application please email or call tollfree . This email and phone number is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes such as following up on an application or technical issues not related to a disability will not receive a response. Smiths Detection Inc. participates in the Electronic Employment Verification Program.
We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race colour religion sex sexual orientation gender identity national origin economic status disability age or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics where we celebrate support and embrace diversity.
At no time during the hiring process will Smiths Group nor any of our recruitment partners ever request payment to enable participation including but not limited to interviews or testing. Avoid fraudulent requests by applying jobs directly through our careers website (Careers Smiths Group plc)
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
