Commissioning and Qualification Engineer II
Commissioning and Qualification Engineer II
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$ 79731 - 94145
1 Vacancy
Job Description
Who we are:
Maravai LifeSciences translates extraordinary science into everyday miracles helping biotech biopharma and life sciences companies everywhere deliver novel vaccines therapeutics and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the worlds leading biopharma vaccine diagnostics and cell and gene therapy companies.
At Maravai we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture where every team member is inspired to bring their best selves to work we cultivate an environment in which we can lead together providing differentiated value to our customers and enabling the miracles of science. For over 35 years Maravais portfolio companies have served as a catalyst for innovative lifesaving technology for humanity. Pioneering nucleotide research since its inception we are now leading the way in the rapidly expanding mRNA market.
Your next role as a Miracle Maker
Maravai LifeSciences is seeking a #MiracleMaker to join our Commissioning and Qualifications team as a Compliance Engineer II. As a Compliance Engineer II you will assess analyze and manage equipment lifecycle activities which includes qualification of Facilities Utilities and Equipment (FUE) and Computer System Validation (CSV). You will also work to identify areas to improve productivity efficiency and maintain compliance. The CE II will also develop and evaluate new compliance methodologies and/or procedures.
How you will make an impact:
- Participate in URS development System Impact Assessment and System Risk Assessment establishing system boundaries and traceability matrix to support C&Q deliverables
- Support operational practices: Asset Management and Decommissioning
- Collaborate with endusers process owners quality engineers and other team members
- Develop executes and documents FUE IOPQs Cleaning Validation and CSV using Good Documentation and Good Engineering Practices GDP GEP and GAMP
- Oversee vendor execution of IQ OQ PQ for FUE laboratory equipment and instrument
- Analyze test results and develop qualification summary reports
- Initiate change controls deviations/exceptions investigations corrective/preventive actions root cause analysis
- Coordinates C&Q activities/deliverables with other groups using Project Management tools to ensure projects are carried out on time
- Accountable for C&Q activities supporting the site FUE
- Revising and maintaining equipment lifecycle documentation related to C&Q GEP and GAMP5
- Maintains uptodate knowledge of validation requirements practices and procedures across industry
- Assure compliance with allinhouse or external specifications to standards such as ISO GMP and 21 CFR Part 11
- Ensures adherence and compliance to prestart up safety checks LOTO and site safety programs
The skills and experience that you will bring:
- Bachelors degree or equivalent in a scientific discipline (Masters a plus)
- Quality professional with a minimum of 3 years relevant experience in a life science industry (2 years in cleaning validation and computer system validation is a plus)
- Requires knowledge of FDA regulated biotechnology or drug validation requirements (e.g. 21 CFR 210 211 or ICH Q7)
- Knowledge of GEP and GAMP5 integrated C&Q process application of risk management to GEP and GAMP5 and relationship between CQAs CPPs Cas CDEs and the associated testing
- Experience executing validation projects for biotech or pharmaceutical projects
- Must have specific knowledge of validation methodologies and principles
- Strong technical writing and analytical skills
- Experience in risk management and application of FMEAs to validations
- Experience in the use of MS Project Master Control eMaint Rees
The anticipated salary range for this position is $79731 $94145. In addition highly competitive longterm incentives in the form of company equity bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidates skills experience and other qualifications as well as the location of the role.
#LIOnsite
The benefits of being a #MiracleMaker:
- You have the potential to change improve and save lives around the world.
- You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
- We offer comprehensive medical plans and HSA/FSA options.
- Fertility & family planning assistance.
- A variety of additional optional benefits and insurance options including pet insurance.
- Retirement contributions.
- Holidays & Paid Time Off.
Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at ourBenefits & growth site at view more opportunities to become a #MiracleMaker visit our career site at LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex including sexual orientation and gender identity national origin disability protected Veteran Status or any other characteristic protected by applicable federal state or local law.
Click here to view Maravai LifeSciences Privacy Notice
HIRING SCAM ALERT
Recently individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists please be aware that:
- Maravai LifeSciences will never interview a candidate over RingCentral similar messaging apps or social media (e.g. Telegram Google Hangouts WhatsApp Facebook Messenger etc.)
- Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
- Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences please reach out to us directly at . If you believe you have been a victim of fraud you can report this activity at: or .
Employment Type
Commission
