Manufacturing Engineer II
Onsite - San Diego, CA
Schedule:
Monday - Friday, 8am - 5pm
Duration:
3-Month Initial Contract (potential for extension/conversion)
Pay:$39-42/hr (W2)
Our client is a leading global biotechnology company specializing in genomic sequencing and array-based solutions. They are seeking a Manufacturing Engineer II to support manufacturing and product quality activities within their Manufacturing/Operations Quality organization. This onsite role requires exceptional communication, interpersonal, and project management skills to effectively coordinate activities and deliver results in a regulated manufacturing environment.
Essential Functions and Responsibilities
- 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
- Ensure 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 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 in order to improve product and process
- Develop recommendations based on data analysis
- Collaborate with counterparts and cross-functional teams at other company sites
- Support change management activities, equipment lifecycle, and meeting facilitation
- Support day-to-day sustaining activities and continuous improvement initiatives
- Provide quality oversight for manufacturing areas
- Other activities as assigned
Education and Experience
- Bachelor's degree in Science or Engineering
- 2+ years professional experience in a regulated manufacturing environment
Knowledge and Skills
- Familiarity with GMP and working in a regulated environment
- Experience with Nonconformance Reports (NCR)
- Knowledge of equipment lifecycle including onboarding, validation, and maintenance
- Strong written and oral communication skills
- Understanding of process risk/pFMEA
- Problem solving and root cause analysis skills
- Team player with accountability for actions
- Active participation in team meetings and discussions
- Project management and coordination abilities
- Exceptional interpersonal and relationship building skills
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