Jobs at The Spear Group (Now Hiring) — 2 open

Be part of a high performing team accountable for overseeing projects assisting a growing portfolio of small molecule related work. Bring forward strong subject matter expertise to lead studies and evaluations, determine suitability, establish direction, conduct risk assessments, define safeguards, assess operability, interface with vendors, construction, and commissioning, and provide operational readiness. Be exposed to a wide range of biopharma manufacturing operations and capital project areas, including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation. Have responsibilities related to the planning, design, and implementation of engineering solutions on a process/project team within a large capital project, including equip/scope generation, process and facility design, equipment selection, vendor interaction/management, factory acceptance testing, technology transfer support, construction support, equipment qualification, facility start-up, and knowledge transfer. Be part of a cross functional team through drug substance facility and process development projects during design and execution. Champion innovative solutions meeting the objectives of the business. Implement standard work and drive technical areas and small capital projects (process & facility) from an end-to-end perspective. Coordinate and complete projects on time within budget and scope. Oversee all aspects of projects. Set deadlines, assign responsibilities, and monitor and summarize progress of projects. Prepare reports for upper management regarding status of projects. Understand and execute front end project execution through commissioning/qualification. Coordinate internal resources and third parties/vendors for the flawless execution of projects. Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility. Ensure resource availability and allocation. Develop detailed project plans to monitor and track progress. Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques. Measure project performance using appropriate tools and techniques. Report and escalate to management as needed. Manage the relationship with the client and all stakeholders. Perform risk management to minimize project risks. Establish and maintain relationships with third parties/vendors. Create and maintain comprehensive project documentation. Meet with clients to take detailed ordering briefs and clarify specific requirements of each project. Delegate project tasks based on junior staff members’ individual strengths, skill sets, and experience levels. Track project performance, specifically to analyze the successful completion of short and long-term goals. Meet budgetary objectives and make project constraints based on financial analysis. Develop comprehensive project plans to be shared with clients as well as other staff members. Use and continually develop leadership skills. Attend conferences and training as required to maintain proficiency. Develop spreadsheets, diagrams, and process maps to document needs. Enhance department and organization reputation by accepting ownership for accomplishing new and different requests. Explore opportunities to add value to job accomplishments. Perform other related duties as assigned.

REQUIREMENTS: Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Bioprocess Engineering, Biomedical Engineering, Biologics Engineering, or Biotechnology Engineering required. Two years of experience required in a pharmaceutical project engineering role, including any experience with: the drug substance line of business; the pharma/biopharma processing capital equipment life cycle approach including specification, selection, testing and commissioning, troubleshooting, or qualification; project management with the owner’s side responsibilities for cost, quality, scope, design, risk, schedule, and workforce allocation; facilitating on-time delivery and quality work; representing engineering pharma project interests on

collaborative teams for pharmaceutical manufacturing; project leadership in pharma manufacturing capital projects; project design on large capital projects that follow a stage-gate process end-to-end; automation hardware and infrastructure; Microsoft Office and other project management technical tools and dashboards; and with Lean design, delivery, and construction methodologies (Takt, pull planning, and modular construction). May be subject to periodic transfers to unanticipated work locations. Must have legal authority to work in the U.S. EEOE.

Send resume to: Barbara LaCasce at barbara.lacasce@speargroup.com. Please reference NN25 + job title in subject line.

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The Spear Group is an Equal Opportunity Employers. All personnel actions are affected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.

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