Commissioning & Qualification Specialist
About The Position
The Manufacturing Process Engineer – Solid Dosage is responsible for the design, optimization, and continuous improvement of manufacturing processes related to solid oral dosage forms (e.g., tablets, capsules). This role ensures processes are robust, efficient, and compliant with current Good Manufacturing Practices (cGMP) and regulatory requirements. The engineer will collaborate with cross-functional teams including Production, Quality Assurance, Quality Control, Validation, and R&D to support technology transfer, scale-up activities, process validation, and ongoing commercial manufacturing operations.
Requirements
- Fluent in Spanish and English (spoken and written).
- Strong knowledge of cGMP regulations and pharmaceutical manufacturing standards.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
- Strong analytical, problem-solving, and organizational skills.
- Excellent communication and interpersonal skills.
- Ability to work in a cross-functional team environment.
- Ability to manage multiple priorities and meet deadlines.
- High level of attention to detail and commitment to quality
- Minimum of 3 years of experience in pharmaceutical manufacturing.
- Hands-on experience with solid oral dosage forms (tablets, capsules, granulation, compression, coating).
- Experience with process validation, technology transfer, and scale-up activities.
- Familiarity with equipment such as blenders, granulators, tablet presses, and coating machines.
- Experience working in a cGMP-regulated environment is required.
- Ability to work on-site in a manufacturing environment.
- Ability to stand, walk, and move within production areas for extended periods.
- Ability to wear appropriate personal protective equipment (PPE) such as gowns, gloves, masks, and safety glasses.
- Ability to lift up to 25 lbs occasionally.
- Must be able to operate a computer and standard office equipment.
- Ability to work in controlled environments (temperature, humidity, cleanroom conditions).
Nice To Haves
- Knowledge of statistical tools and process capability analysis is a plus.
Responsibilities
- Develop, optimize, and maintain manufacturing processes for solid dosage forms to ensure product quality, efficiency, and compliance.
- Support technology transfer activities, including process scale-up and validation.
- Lead and execute process validation (PPQ), including protocol development, data analysis, and report generation.
- Monitor process performance through data analysis and implement continuous improvement initiatives.
- Troubleshoot manufacturing issues and implement corrective and preventive actions (CAPA).
- Collaborate with Quality teams to ensure compliance with cGMP, FDA, and other regulatory requirements.
- Participate in deviation investigations, root cause analysis, and change control processes.
- Support equipment qualification (IQ/OQ/PQ) and process-related documentation.
- Develop and maintain manufacturing documentation, including batch records, SOPs, and process descriptions.
- Ensure proper implementation of process controls and critical quality attributes (CQAs).
- Provide technical support to production teams during routine manufacturing and new product introductions.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
