Manufacturing/Process Engineer – Barceloneta, PR

The Manufacturing Engineer is responsible of providing technical assistance to the manufacturing areas related to the manufacturing process and equipment. These areas are highly dependent on technique, detailed procedures, equipment and controls. The position requires dealing with difficult technical problems in highly technical and regulated environment. This position requires developing and implementing changes that will improve equipment performance and consequently product quality in the 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 the manufacturing area equipment in compliance with the calibration and maintenance programs.

Responsibilities:

  • Comply with Abbvie 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.
  • Schedules work tasks, without assistance, to support project and campaign timelines.
  • Drafts broad scope and complexity documents. Circulates the documents to reviewers and without assistance responds to comments and questions. Manages document review and approval to meet project timelines.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Tracks ongoing problems and gathers information for analysis. Uses analysis to develop solutions to broad level problems. Presents potential solutions to management and senior personnel, and with limited assistance creates an implementation plan.
  • Develop and implement changes that will improve equipment performance and consequently product quality in the manufacturing areas and reduce manufacturing costs. Evaluate and implement new equipment technology.
  • 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.
  • Give direct support to the manufacturing process and trouble shootings.
  • Provide assistance to operations int he 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.
  • Provide assistance during Regulatory Agency Audits
  • Evaluates data for trends, which may impact other systems, projects, or areas.
  • Applies knowledge, experience, and technical skills to understand production objectives and evaluate potential changes, implement production initiatives. Executes systems and procedures efficiently and compliantly and evaluates systems for improvement potential. Develops and uses standard practices to ensure inter-group consistency.
  • Works’ cross-functionally to enhance systems that improve Good Manufacturing Practice compliance.

Qualifications:

  • Bachelor’s Degree or equivalent required.
  • At least 8 years’ experience in all aspects of manufacturing and production processes.
  • Knowledge Oral Solid Dosage
  • 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 works in a team environment; Maintains 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 participates in the continuous improvement process.
  • Uses problem solving skills when working on complex problems, where analysis of situations requires an in-depth evaluation of various factors.
  • Uses 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.
  • Coordinates the 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 discusses progress, problems, and proposed solutions with colleagues and senior personnel.
  • 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.
  • Excellent verbal and written communication skills in both, English and Spanish.