Providing technical assistance to manufacturing areas related to the manufacturing process and equipment and dealing with difficult technical problems in highly technical and regulated environment. These areas are highly dependent on technique, detailed procedures, equipment and controls.
Develop and implement changes to improve equipment performance and product quality in manufacturing areas and reduce manufacturing costs, maintaining a constant product turnover.
Develop and modify procedures as needed to support the manufacturing operation.
Participate in process, equipment, and facilities validation efforts and project implementations.
Investigate process exceptions or equipment malfunction incidents affecting the process.
Maintain manufacturing area equipment in compliance with calibration and maintenance programs.
Comply with client’s policies and procedures, Engineering Standards and Specifications, and regulatory agency regulations and requirements. Provide technical assistance to the manufacturing areas.
Assist in the troubleshooting of manufacturing equipment and processes. Investigate process and equipment exceptions and follow up CAPA implementation. Revise SOP’s and PCR and submit Change Requests (CR)for approval.
Transfer methods into Production instructions to allow for successful performance of scheduled campaigns.
Schedule work tasks to support project and campaign timelines.
Draft broad scope and complexity documents. Circulate the documents to reviewers and respond to comments and questions.
Manage document review and approval to meet project timelines.
Exercise judgment within broadly defined practice and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
Track ongoing problems and gather information for analysis. Uses analysis to develop solutions to broad level problems and presents potential solutions to management and senior personnel and create an implementation plan.
Initiate capital project ideas dealing with safety, quality improvement, capacity increase, and/or cost reduction.
Establish requirements and assist in the implementation of changes to the Process Control System.
Participate in the development and execution of validation protocols.
Participate in manufacturing personnel training.
Support manufacturing process and trouble shooting.
Aid operations in the control, management, and disposal of household wastes, biomedical and hazardous to their respective areas as applicable, ensuring compliance.
Provide support to supervisors in the batch record audit process and discrepancies closures.
Help during Regulatory Agency Audits.
Evaluates data for trends, which may impact other systems, projects, or areas.
Bachelor’s Degree or equivalent required.
At least 8 years’ experience in all aspects of manufacturing and production processes.
Knowledge Oral Solid Dosage.
Detailed understanding of current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility. Able to make recommendations for improved compliance at plant level. In-depth knowledge of pertinent regulatory filings. Uses knowledge to prevent problems with regulatory authorities.
Knowledge in manufacturing equipment troubleshooting.
Apply knowledge, experience, and technical skills to understand production objectives and evaluate potential changes, implement production initiatives.
Execute systems and procedures efficiently and compliantly and evaluate systems for improvement potential.
Develop and use standard practices to ensure inter-group consistency.
Work cross-functionally to enhance systems that improve Good Manufacturing Practice compliance.
Excellent verbal and written communication skills in both, English and Spanish.
Computer and scheduling expertise; In-depth knowledge of safety, quality systems and Good Manufacturing Practices required.
Expertise with and continuous improvement and tech transfer processes.
Must be flexible to handle multiple tasks including ability to handle pressure in a professional and positive manner.
Effectively work in a team environment.
Maintain high level of energy and professionalism on the job.
Build effective working relationships with customers, co-workers, cross-functioned groups, and management.
Proactively and effectively participate in continuous improvement process.
Use problem solving skills when working on complex problems, where analysis of situations requires an in-depth evaluation of various factors.
Use discretion and exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Reports to a manager or higher.
Coordinating completion of programs and projects. Decisions, recommendations, and actions are essential to the development of suite schedules and personnel allocation.
Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.
Regularly discuss progress, problems, and proposed solutions with colleagues and senior personnel.