Senior Process Engineer, Massachusetts

Job Description

Purpose

This Senior Process Engineer is responsible for providing engineering support for New Product Introduction (NPI) within an active Biologics manufacturing facility. This includes support of facility fit assessment through Master Record generation and manufacturing startup. This engineering professional, who, working with little or no supervision, applies scientific knowledge, engineering knowledge, and mathematics to support and execute NPI, manage medium to large projects, equipment optimization, and maintain/track assigned priorities. This individual will leverage their knowledge of other related disciplines beyond their own area of expertise to support NPI. This individual requires strong projection management skills as they will be working with other engineering functions, operations and S&T to complete the full scope of NPI.

Responsibilities

Leads facility fit activities for New Product Introduction (NPI) from clinical phase 1 to commercial projects with little to no supervision. NPI activities also include equipment walkdowns, batch record review, leading technical discussions and working with vendors.

Effectively assesses and prioritizes mid to long term objectives/tasks and translates them into actionable work streams.

Responsible for compliance with applicable policies and procedures. Leads early risk assessments and evaluation of potential consequences (defects and failure modes) of design changes to established processes.

Mentors engineering staff and serves as a technical leader for matters associated with biologics manufacturing and tech transfer.

Plans and conducts medium to large projects related to bioprocessing equipment and process improvements. Projects may require refining of a given scope and determining overall action plan and timelines. Additionally, it requires generation of validated change plans with validation requirements. Able to execute actions of those plans with minimal oversite and resolve issues as they arise with minimal to no support.  Communicate progress to all stake holders through verbal and written communications.

Leads troubleshooting activities with little to no oversight to resolve process/equipment anomalies. Describes and communicates required actions to internal and external stakeholders 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 strong process and engineering knowledge to identify issues on the production floor proactively.

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.

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.

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.

Leads experiments/gathers data to perform detailed analysis and assess relevance to conceptualize complete solutions.  Creates or coordinates the design solutions for moderately 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 with minimal support from management.