Type: Contract, W2 only
Duration: 24+ months
Location: Tucson, AZ (Oro Valley)
Pay: $36/hr-$39/hr, DOE
Please note that at this time we are unable to sponsor employment authorization (both new and transfer)
A leading Global Biotech Company is seeking a Process Development Engineer who will focus on continuous improvement, design, automation, cGMP compliance, and quality management of the company's manufacturing processes. You will evaluate existing processes and equipment to identify and implement opportunities for enhanced efficiency and effectiveness, leading Lean Manufacturing initiatives in partnership with the Process Engineering & Validations team. Your responsibilities will also include designing and implementing automation solutions to streamline manufacturing processes and supporting the Automation Technician team in resolving technical and compliance issues related to manufacturing equipment.
Responsibilities:
Process Engineering & Improvement (60%)
- Design, develop, and improve manufacturing processes for new and existing products (aiming for reduced cycle time).
- Analyze process data and perform troubleshooting to resolve technical issues and decrease downtime.
- Design and implement automation solutions to streamline processes.
- Support process validation and qualification activities.
- Utilize process simulation software and engineering tools for optimization.
- Manage project timelines for equipment repairs, maintenance, and upgrades.
Compliance & Quality (10%)
- Ensure strict adherence to current Good Manufacturing Practices (cGMP) and internal quality standards.
- Maintain documentation (flow diagrams, work instructions, reports).
- Conduct risk assessments and develop mitigation strategies.
- Assist in audit readiness and Non-Conformance Report (NCR) investigations.
- Identify and escalate potential safety hazards.
Continuous Improvement (30%)
- Apply Lean principles to eliminate inefficiencies and waste.
- Use problem-solving methodologies (e.g., Five Whys, Fishbone diagrams) for root cause analysis.
- Use statistical tools (e.g., Minitab) to analyze data and generate actionable insights.
- Establish and maintain Overall Equipment Effectiveness (OEE) improvement plans and track performance metrics.
- Develop and maintain standardized procedures and documentation.
Maintenance
- Develop and implement comprehensive preventive maintenance plans for manufacturing and test equipment.
- Coordinate with maintenance teams for scheduled maintenance, service, and calibrations.
Qualifications:
- Bachelor's Degree (required), preferably in Engineering/Engineering Technology or a Life Science discipline.
- 2-5 years of relevant work experience.
- Basic knowledge of GMP and regulatory standards.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
- Knowledge of Lean principles and/or Six Sigma methodologies (preferred).
We are an Equal Opportunity employer and welcome talent across all aspects of background, orientation, origin, and identity in an inclusive and non-discriminatory way. Applicants receive consideration without bias and based on the relevant qualifications, talents, skills, experiences, and business needs.