Manufacturing Engineer - Barceloneta, Puerto Rico - AbbVie

Descripción

The Manufacturing Engineer is responsible of providing technical assistance in the Bulk Drug Substance (BDS) area 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 a 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.
• 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 in the control, management and disposal of household wastes, biomedical and hazardous to their respective area as applicable, ensuring compliance with federal and local regulations and policies following plant, division and corporate procedures.
• Provide support to supervisors in the batch record audit process and discrepancies closures.
• Provide assistance during Regulatory Agency Audits.

Significant work activities:

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
• Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
• Continuous walking for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
• Work in a clean room environment

Qualifications

• Bachelors Degree in Engineering is required (Chemical or Mechanical preferred)
• Requires minimum two (2) years of total combined experience in Process / Equipment or Manufacturing Engineering of a Pharmaceutical, Biotechnology, API or Medical Devices industry.
• Previous experience experience in the manufacturing environment of Pharmaceutical, Biotechnology, API or Medical Devices industry.
• Knowledge in manufacturing equipment troubleshooting.
• Previous experience with Control Systems; DeltaV and MES preferred.
• Knowledge of quality regulations and standards affecting chemical, biological or medical devices. knowledge of corporate, local, state, and OSHA regulations.
• Excellent verbal and written communication skills in both, English and Spanish.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. ​

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AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.