AbbVie Process Engineer Manager in Worcester, Massachusetts
An Engineering Manager is responsible leading a team of Engineers in support of Cell Culture and Purification activities within Biologics manufacturing. This engineering professional who, working with little or no supervision, applies scientific knowledge, engineering knowledge, mathematics, to lead equipment and process troubleshooting, New Product Introduction (NPI), manage/support medium to large projects, equipment optimization, and maintain and track area priorities. The Engineering Manager has general knowledge of other related disciplines beyond their own area of expertise.
Accountable for the development and assignment of work for a team of Engineers supporting Cell Culture and Purification operations. Mentors engineering staff and serves as a technical leader for matters associated with their responsible area. Leverages team to effectively drive both tactical and strategic priorities.
Effectively assess and priorities both short to long term objectives and tasks for their area of responsibility and translate them into actionable work streams for engineering staff.
Responsible for compliance with applicable policies and procedures. Ensures quality and effectiveness of key results of major projects within function through sound design, early risk assessments, and implementation of fallback strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes .
Assure s fulfillment of environmental, health, and safety (EHS) requirements and compliance obligations, promote s continuous improvement, and consider s EHS aspects during day to day activities .
Oversees process monitoring of manufacturing operations, as well as Steam in Place (SIP) and Cleaning in Place (CIP) operations. Leads troubleshooting activities and mentors less senior engineering staff to resolve process/equipment anomalies. Describes and communicates required actions to internal and external stake holders with varying levels of technical acumen. Engages with operational staff on the floor in a GMP cleaning room setting to understand what activities are being performed. Leverages extensive process and engineering knowledge to identify issues on the production floor proactively and innovate solutions.
Leverages engineering and process background to execute facility fit activities independently in support of New Product Introduction (NPI) from clinical phase 1 to commercial projects. NPI activities also include equipment walkdowns, batch record review, Leading technical discussions and working with vendors. It is expected that Principal Engineers are an integral part of the NPI process often bridging the gap between Develop and Operational groups.
Builds relationships, initiates and cultivates open, honest relationships with colleagues, customers, contractors, and vendors by establishing rapport, developing an understanding of others’ needs, promoting common goals, and following through on commitments.
Conveys information effectively through verbal, written, and presentations to stakeholders and team members, both internal and external to AbbVie, using appropriate communication protocols. Identifies ways to increase customer satisfaction. Documents agreements and commitments and keeps direct customers informed
Interprets problems and either creates or modifies design solutions. Reviews existing layouts and standards and creates a proposed design. Applies standard engineering principles and methodologies to interpret, draw conclusions and recommend solutions for problems considering a broad range of factors. Improves methods/designs/processes. Recognizes and implements innovations and cost reductions.
Facilitates the definition of a project scope with stakeholders. Converts goals to tasks and steps. Within structure, plans own work, manages several, often concurrent, tasks to accomplish assigned tasks to meet or exceed expectations (cost, quality, time). Participates in basic economic analysis and feasibility studies related to project alternatives under guidance. Jointly responsible for achieving the project’s financial targets in support of business objectives.
Plans and conducts medium to large sized assigned projects related to bioprocessing equipment and process improvements requiring custom, risk-managed execution plans, investigations, and/or equipment. Manages multiple, often concurrent, projects and meets deadlines. . Projects may require identification of scope and determining overall action plan/timeline and generation of validated change plans. Able to execute actions of those plans with minimal oversite and independently resolve issues as they arise. Communicate progress to all stake holders through verbal and written communications.
Designs and leads experiments / gathers data to perform detailed analysis and ass ess relevance to conceptualize complete solutions. Creates or coordinates the design solutions for novel or complex problems; integrates regulatory and operational needs; assesses cost benefit. Explores multiple alternatives. Structures studies and integrate cross-disciplinary and cross-functional issues to arrive at optimal cause of action.
Applies technology in innovative ways. Combines technologies to anticipate or address site/ customer needs; shares solutions across sites; employs proven solutions to increase effectiveness of engineering methodology or manufacturing process. Mentors others by sharing technical expertise and providing feedback and guidance.
Interacts with both senior management and external personnel on significant technical matters often requiring coordination between organizations. Balances bottom line objectives with long-term interest of the site/ customer. Is identified as a Subject Matter Expert in the discipline. Participates in internal teams to develop and align procedures and standards. May influence validation strategy.
Supports Project definition, request capital expenditure (RCE) development, engineering cost estimate, design, project plan integration, construction, commissioning, qualification, and startup.
Supports the Long-Range Planning (LRP) related to capacity, pipeline technology assessment, facility asset utilization, and capital investments.
Support capital project execution in the areas of design, validation, FAT, SAT, and specification review, for production equipment.
• Bachelors Degree in Engineering, science, or closely related discipline is desired, or equivalent technical
experience plus demonstrated competence, with a desired 8 + years of significant engineering and/or operational
experience. A postgraduate education/degree is desired, and may contribute towards the desired years of
• Has demonstrated a consistent series of technical contributions and accomplishments .
• Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on
problems of complex scope where analysis of situations or data involves multiple competing factors.
Demonstrates judgment within defined procedures and practices to determine appropriate action.
• Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
• Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective
orally, in writing, and in presentations.
• Works well with other engineers in a collaborative, fastpaced goaldriven environment.
• Demonstrates leadership ability with direct reports and/or cross functional teams
• Possesses interpersonal skills to negotiate and reconcile differences.
• Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries .
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