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Manufacturing Process Specialist
2 months ago
Position Summary:
The Process Engineer within the PharmBio division plays a crucial role in supporting the daily operations of pharmaceutical containment manufacturing. This position leverages expertise in quality systems to ensure adherence to established standards, including those set by ILC Dover and ISO 9001. The engineer will be responsible for identifying areas for continuous improvement and engaging in collaborative efforts to implement solutions effectively. Additionally, the role may involve direct interactions with clients during audits and addressing customer feedback.
Key Responsibilities:
- Provide comprehensive technical support, including equipment testing, process monitoring, and risk assessment evaluations.
- Ensure all manufacturing equipment and processes are thoroughly documented through standard operating procedures (SOPs).
- Drive continuous improvement initiatives by revising, implementing, or creating standard work for SOPs and new methodologies.
- Support troubleshooting efforts for equipment issues within the manufacturing environment, ensuring optimal performance according to specifications.
- Develop validation protocols based on thorough risk assessments and manage revalidation processes.
- Lead and coordinate projects related to product development and process optimization.
- Design and enhance processes from initial conception through to validation and certification.
- Prepare and deliver technical presentations and program updates to team members and management.
- Conduct measurements, testing, and data analysis to enhance production efficiency and established processes.
- Maintain up-to-date knowledge of relevant government and industry quality standards, including ISO 9001:2015.
- Effectively manage project costs and timelines.
- Document processes and provide operational instructions for manufacturing activities.
Qualifications:
- Bachelor's degree in Engineering or a related technical field.
- A minimum of 5 years of relevant industry experience.
- Experience with CAPA, root cause analysis, and 8D methodologies.
- Certification as a Six Sigma Green Belt or Black Belt.
- Proficiency in word processing, statistical analysis software (SPC), CAD or Auto-Cad, and database management.
- Strong skills in Microsoft Office Suite.
- Experience with measurement, calibration, and testing equipment.
- Demonstrated analytical and problem-solving capabilities.
- Excellent written and verbal communication skills.
- Detail-oriented with strong organizational skills.
- Knowledge of safety and hygiene practices.
- Able to thrive in a collaborative team environment.
Preferred Qualifications:
- Master's degree or advanced qualification in Engineering or a related discipline.
- Experience in clean room and aseptic manufacturing settings.
- Mechanical aptitude with troubleshooting skills.
- Familiarity with manufacturing methods and quality standards (ISO 9001:2015, 13485:2016, 21CFR820, 21CFR211).
Work Environment: The characteristics of the work environment described here are typical for individuals performing the essential functions of this role. Reasonable accommodations may be made for individuals with disabilities. The employee may frequently work near moving mechanical parts and may occasionally be exposed to fumes or airborne particles. The noise level is generally moderate.
Physical Requirements: The physical demands outlined here are representative of those required to successfully perform the essential functions of this position. Reasonable accommodations may be made for individuals with disabilities. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds. Specific vision abilities required include close vision, color vision, distance vision, and depth perception. Regular walking, talking, and hearing are essential, along with frequent standing and hand usage. Occasional sitting, stooping, kneeling, crouching, or crawling may also be required.
Equal Opportunity Employer: ILC Dover is committed to fostering a diverse workforce and offers competitive benefits, including medical, dental, life insurance, 401(k), and paid time off.
