C4652a-US- Mfg​/Ops Quality Engineer ; Contractor

Yoh is hiring a Manufacturing/Operations Quality Engineer 2 for one of their biotechnology clients in the San Diego, CA area. If interested, please send your updated resume to

Client: Biotechnology company

Duration: 4 month contract - likelihood of extension

Location: Onsite @ San Diego, CA 92122

Pay: $35-44/hr w-2 basis

Shift: M-F, 8a-5p

This position is responsible for manufacturing and product Quality activities. This role is within Manufacturing/Operations Quality organization and is accountable for supporting day to day sustaining activities in a manufacturing environment. The position requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results.

This position will have direct interaction with Manufacturing and Process Engineering groups to support manufacturing sustaining activities, continuous improvement, and manufacturing capacity expansion. The position may also have quality oversight for more than one manufacturing area. The position will be responsible to support change management activities, Nonconformances, equipment lifecycle, meeting facilitation and other ad hoc sustaining manufacturing requests.

• Provide ongoing quality engineering support throughout the product life cycle.
• Provide support to engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements.
• Ensures adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions.
• Support process risk management activities and ensure quality and completeness of validation packages, and change orders.
• Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
• Review verification and validation reports and identify gaps for GMP compliance.
• Develop and execute strategies to close gaps in an efficient, technical, and compliant manner.
• Coordinate issue resolution using a risk-based approach.
• Ensure manufacturing processes and validation programs meet requirements of FDA and ISO.
• Trend, analyze, and report on quality data to improve product and process; develop recommendations based on data analysis.
• Collaborate with counterparts and cross‑functional teams at other client sites.
• Other activities as assigned.

• 2-5+ years of related experience and a Bachelor's degree in engineering/science
• Familiarity with GMP, working in a regulated environment, and Nonconformance Reports (NCR)
• Knowledge of equipment lifecycle (including onboarding, validation, maintenance)
• Strong communication skills (written and oral)
• Process risk/pFMEA experience
• Experience with problem solving/root cause analysis tools

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note:

Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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