Principal Engineer

4 weeks ago


Boston, United States BioSpace, Inc. Full time

Job Description Are you ready for an exciting career opportunity? We are currently seeking a highly motivated and skilled Principal Engineer to join our team. If you're looking for a challenging role where you can make a significant impact, this is the perfect opportunity for you. As the Principal Engineer, you will be responsible for managing the engineering New Product Introduction (eNPI) process within our dynamic and innovative Biologics manufacturing facility. This includes conducting facility fit assessments, generating Master Records, and overseeing the manufacturing startup. You will have the chance to apply your scientific knowledge, engineering expertise, and mathematical skills to execute New Product Introduction (NPI) projects. Additionally, you will play a key role in managing and supporting medium to large-scale projects, optimizing equipment, and effectively prioritizing tasks. Collaboration is essential in this role, as you will work closely with other engineering functions, operations, and S&T teams to ensure the successful completion of the NPI process. As a Principal Engineer, you have the potential to transition into an Engineering Manager role. This leadership position involves leading a team of 5 to 8 individuals who directly support NPI activities. By demonstrating your exceptional skills and leadership abilities, you can further enhance your impact and influence within our organization. This is an exciting opportunity to not only contribute to the success of our Biologics manufacturing facility but also to develop your leadership capabilities and shape the future of our engineering team. Don't miss out on this incredible chance to take your engineering career to new heights. Apply now and embark on an exciting journey with us Responsibilities: 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. 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 biologics manufacturing and tech transfer. Leverages broader team to effectively drive both tactical and strategic priorities. Effectively assess and priorities both short to long term objectives and tasks translate them into actionable work streams. 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. Assures fulfillment of environmental, health, and safety (EHS) requirements and compliance obligations, promotes continuous improvement, and considers EHS aspects during day to day activities. 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. 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 projects 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 assess 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. Qualifications A 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 post-graduate education/degree is desired, and may contribute towards the desired years of experience. Has demonstrated competency within a discipline. Has a career history marked by a consistent series of technical contributions and accomplishments. Significant contribution to product or process development or improvement through creative application of technical effort will equally be recognized. 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. Exercises judgment and advises management as to the appropriate actions. 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, fast-paced goal-driven environment. Possesses interpersonal skills to negotiate and reconcile differences. Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).

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