Senior Engineer Manager - Upstream

Role Summary

Senior Engineer Manager - Upstream. Location: ANC. You will be responsible for the department capital portfolio and project management of small capital projects at the drug substance facility in ANC. You will provide technical leadership to a team of manufacturing support engineers supporting commercial production operations with emphasis on Drug Substance bioprocessing equipment. You will collaborate with Manufacturing, Quality, Process Development, Maintenance, and network partners to ensure safe, compliant operations and to drive performance improvements and sustainability initiatives.

Responsibilities

• Providing technical leadership to a team of manufacturing support engineers supporting commercial production operations with emphasis on Drug Substance bioprocessing equipment.
• Establishing clear expectations and priorities to staff; fostering a culture of continuous improvement, partnership, and knowledge sharing; providing development opportunities and feedback.
• Cultivating a culture of safety and driving efforts to reduce safety risks.
• Providing technical support to troubleshoot, identify, and resolve process and system issues as needed.
• Being knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance.
• Collaborating with key customers and support groups (Manufacturing, Quality, Process Development, Maintenance, network partners).
• Ensuring all tasks and projects are accomplished in a safe manner.
• Employing Business Analytics to assess performance and identify improvement opportunities.
• Leading Sustainability Program Management of multi-faceted, cross-functional, network initiative.
• Collaborating with leadership to set strategy and business objectives.
• Fostering and maintaining relationships with key stakeholders.
• Establishing a balanced scorecard of strategic and operational KPI to monitor, trend and analyze equipment performance, sustainability and reliability programs.
• Ensuring action plans are established to address performance gaps or opportunities.
• Communicating gaps and establishing the proper escalation process to stakeholders.
• Identifying opportunities to optimize organizational efficiency.
• Leading engineering and contractor evaluation and selection.

Qualifications

• Required: High school diploma / GED and 12 years of Engineering and/or Project Management experience OR Associate’s degree and 10 years of Engineering and/or Project Management experience OR Bachelor’s degree and 8 years of Engineering and/or Project Management experience OR Master’s degree and 6 years of Engineering and/or Project Management experience OR Doctorate degree and 2 years of Engineering and/or Project Management experience
• Required: Additionally, a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Managerial experience may run concurrently with the required technical experience.
• Preferred: Bachelor’s degree in chemical engineering or related technical field
• Preferred: 5+ years’ experience in engineering in a manufacturing support environment with 3+ years’ experience in the Pharmaceutical or Biotechnology industries
• Preferred: Demonstrated people management/leadership experience
• Preferred: Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP and Production Services. Upstream unit operation experience such as bioreactor or harvest equipment
• Preferred: Familiarity designing, troubleshooting, and operating equipment used in cell culture manufacturing including disposable technologies
• Preferred: Experience with Tech Transfer, Process Design, and Commissioning & Qualification
• Preferred: Experience with validation and change control methodology
• Preferred: Direct experience with regulated environments (i.e., cGMP, OSHA, EPA) including detailed understanding of cGMPs
• Preferred: Excellent written and verbal communication skills
• Preferred: Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment
• Preferred: Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
• Preferred: Demonstrated ability to lead and influence cross-functional teams and embrace a team-based culture
• Preferred: Familiarity with designing and operating equipment used in biopharmaceutical manufacturing
• Preferred: Demonstrated experience in applying Operational Excellence and Lean Manufacturing