What are the responsibilities and job description for the Manufacturing Technical Specialist position at Tailored Management?
Job Title: Manufacturing Technical Specialist
Location: 4625 NE Brookwood Parkway, Hillsboro, OR 97124
Contract Duration: 6 months (with potential for full-time conversion)
Compensation: $ 29.79 - $46.81 per hour (W2), based on experience
Job Description
This role is part of a drug product and finished goods manufacturing organization responsible for the reliable delivery of commercial and pipeline products. The operations team is divided into two value streams, working together to produce millions of units of life-saving medicine annually.
This position focuses on the fill-finish value stream and involves collaboration with frontline staff, quality teams, and engineering to oversee, manage, and optimize manufacturing processes.
Key Responsibilities
- Drive business process improvements to enhance operational performance, quality, process reliability, efficiency, and compliance.
- Support process development, validation, tech transfer, and continuous improvement initiatives.
- Conduct batch record reviews, root cause analysis, and corrective/preventive actions (CAPA).
- Own and improve quality documents while defining key performance indicators and generating insights through data analytics.
- Manage strategic direction and execution of programs related to process development, quality, and compliance.
- Develop solutions for complex operational challenges while maintaining safety, quality, and production standards.
- Review manufacturing processes, equipment, and facilities to ensure compliance with industry regulations.
- Lead root cause analysis and problem-solving initiatives to minimize operational issues.
- Support regulatory inspections and act as a Subject Matter Expert (SME) on technical topics.
- Provide technical support for product transfers, new equipment start-up, and process optimizations.
- Train and mentor staff in Lean principles, root cause analysis, and project management.
Qualifications & Skills
- Bachelor's degree in life sciences, physical sciences, engineering, or equivalent experience.
- 5 years of experience in the pharmaceutical industry.
- Strong problem-solving skills with the ability to troubleshoot process-related issues.
- Experience working with large datasets and deriving actionable insights.
- In-depth knowledge of Good Manufacturing Practices (cGMPs) in aseptic processing.
- Familiarity with aseptic manufacturing equipment, sterilization systems, and quality assurance principles.
- Ability to work independently within broad guidelines while handling complex situations.
- Proven experience in continuous improvement initiatives and stakeholder management.
Salary : $30 - $47