Job Title ENGINEER
Job Family Engineering
Job Category Full-Time
Job Classification Experienced/Established
Division Global Pharmaceutical Operations
Relocation Assistance None
At Abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide. Today, Abbott’s nearly 90,000 employees are doing work that matters.
Job Description Introduction of new biopharmaceutical product manufacturing by authoring, and managing the approval of production (fermentation and purification) records and procedures. Ensures that documents include all technical transfer requirements, incorporate site standards, accurately lists materials and are consistent with the capabilities of assigned equipment. Transfer operating instructions to Production personnel in accordance with project timelines. Coordinate and drive review of these documents to include resolution of comments and questions.
Manage and write nonconformity reports (NCRs) and deviations, as member of a group providing technical support to a biologics production unit. Provide timely investigations to include root cause analysis and corrective action plans. Document nonconformity events and corrective action plans within quality system. Organize team of subject matter experts (SMEs) from operations, technical development groups, engineering, validation and quality groups. Chair meetings to determine root cause and establish appropriate corrective actions. Perform engineering evaluations in support of the investigations and corrective actions, and implement corrective actions as required by quality assurance procedures and directives. Report NCR status to management and drive NCR process to maintain key quality performance indicators below specified limits.
Provide engineering support of process and equipment changes required for New Product Introduction (NPI) to include change control and validation of modifications/ improvements made to process equipment and process control system. Support maintenance activities by providing engineering inspections, evaluations and plans. Work with Maintenance, Metrology, Production Operations and contractors to minimize the impact of preventative maintenance and demand repairs on production schedules.
Delivery of high quality production records and procedures, which ensure Right the First Time (RFT) manufacturing of clinical and commercial products..
Provide timely documentation, investigation and closure of NCR process within quality system.
Establish root cause of manufacturing nonconformities utilizing quality tools such as fish bone, 5Ms and 5 Whys methods. Evaluate equipment, process and methods in support of investigations, corrective action and production improvements. Implement actions identified by investigation process, which are intended to mitigate recurrence of the same or similar events in the future.
Support manufacturing operations by providing process monitoring and troubleshooting. Provide engineering support for NPIs by reviewing processing records and procedures, implementation of engineering equipment modifications and controls changes, validation of engineering changes and product change-over. Assist in the maintenance of fermentation and purification equipment by providing coordination of, directions for and review of maintenance and calibration activities, as needed.
Skills/Experience Requirements Basic Qualifications:
• Exchanges information with appropriate frequency and within a time frame to maximize its utility and to promote cross-functional collaboration; verifies information is understood by recipient.
• Presents ideas clearly, succinctly, precisely and with personal commitment
• Conveys information effectively through formal and informal documents,
• Confronts issues in a constructive manner and at an appropriate organizational level; takes ownership of project.
• Grasps complexities and sees relationships among data; determines consequences and alternatives; makes recommendations, e.g. develops a process improvement for manufacturing; analyzes problems from multiple perspectives.
• Identifies and quantifies technical risks and their consequences relative to the success of part of a project; recommends appropriate action.
• Working knowledge of media/buffer preparation, cell culture or purification of biological drugs.
• Computer proficiency`
• A working knowledge of safety, quality systems, and cGMPs.
• Typically applies technical standards and techniques.
• Exercises judgment within defined procedures and policies to determine appropriate action. Discusses action with senior staff.
• Coordinates the completion of daily/weekly tech transfer activities within own area.
• Understanding of cGMPs as applied to equipment and process steps in area of responsibility.
• Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner.
• Effectively work in a team environment.
• Must maintain high level of energy and professionalism on the job.
• Build effective working relationships with customers, co-workers, cross-functioned groups, and management.
BS in Engineering or a minimum of 5 years of manufacturing experience working at a biopharmaceutical production facility.
The ideal candidate will have a Bachelors degree in engineering with 2+ years relevant biologics experience.
Education Requirements The ideal candidate will have a Bachelors degree in engineering.
Significant Work Activities & Conditions Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Percent of Travel 0 – 20 %
Site Location Worcester, MA
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