Hybrid Senior C&Q Engineer presso Trilink biotechnologies
Trilink biotechnologies · San Diego, CA, Stati Uniti d'America · Hybrid
Oyster – Assumi a livello globale con Oyster. Semplifica le buste paga e la conformità.
Sponsorizzato da OysterMaravai 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 world's 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, Maravai’s 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 engineering team as a Senior C&Q Engineer. As a Senior C&Q Engineer you will provide critical guidance in the development of User Requirement Specifications (URS), System Impact Assessments, and risk assessments while ensuring compliance with industry standards such as ISO, GMP, and 21 CFR Part 11. The Senior C&Q Engineer will oversee qualification activities, mentor cross-functional teams, and manage documentation related to equipment lifecycle and validation processes. This role is essential for maintaining the quality and integrity of our operations, contributing to successful project execution and adherence to safety protocols.
How you will make an impact:
- Provide C&Q guidance and participate in:
- URS development, System Impact Assessment and System Risk Assessment, establishing system boundaries and traceability matrix to support C&Q deliverables
- Audit Preparation and Readiness with Quality, Compliance and Safety
- Change controls, deviations/exceptions, investigations, corrective/preventive actions, root cause analysis
- Responsible for reviewing technical requirement specifications and C&Q lifecycle documentation such as URS, FRS, SIA, SRA, Commissioning and Qualification tests, P&IDs, FAT, SAT
- Accountable for C&Q activities supporting the site FUE
- Support Asset Management and Decommissioning
- Leads, develops, executes and documents FUE IOPQs, Cleaning Validation, and Computer System Validation using Good Documentation and Good Engineering Practices, GDP and GEP
- Revise and maintain equipment lifecycle documentation, policies, standards and procedures related to C&Q, GEP and GAMP-5
- Coordinates qualification activities/deliverables with internal and external partners to ensure projects are carried out on time.
- Mentor and coach engineering, manufacturing, and quality personnel on the best practices for qualification and validation
- Maintains up-to-date knowledge of validation requirements, practices and procedures across industry
- Manage oversight of 3rd party organizations with inspections, document redline, review of C&Q supporting documentation
- Assure compliance with all-in-house or external specifications to standards, such as ISO, GMP and 21 CFR Part 11.
- Ensures adherence and compliance to pre-start up safety checks, LOTO and site safety programs specifications to standards, such as ISO, GMP and 21 CFR Part 11.
- Perform other functions and duties as required
The skills and experience that you will bring:
- Bachelor’s degree or equivalent in scientific discipline
- Quality professional with a minimum of 5 years’ relevant experience in the life science industry including 5 years in equipment qualification and/or computer system validation (cleaning validation knowledge 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 GAMP-5, integrated C&Q process, application of risk management to GEP and GAMP-5 and relationship between CQAs, CPPs, CAs, CDEs and the associated testing.
- Experience executing validation projects for biotech or pharmaceutical projects
- Experience in validating CMMS is a plus
- Must have specific knowledge of validation methodologies and principles
- Strong technical writing and analytical skills
- Expertise in risk management and application of FMEAs to validations.
- Experience in the use of MS Project, Master Control, eMaint, Rees is a plus
#LI-Onsite
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 our Benefits & growth site at https://www.maravai.com/careers/benefits-and-growth/
To view more opportunities to become a #MiracleMaker, visit our career site at https://www.maravai.com/careers/
Maravai 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 taops@maravai.com. If you believe you have been a victim of fraud, you can report this activity at: www.iC3.gov or www.stopfraud.gov.
