Senior Manager Process Engineering - Bulk Drug Substance - Downstream

Senior Manager Process Engineering Downstream

In this vital role, you will oversee the engineering team, lead technical projects, and drive innovation in product design and manufacturing processes. You will solve complex engineering problems, optimize processes, and ensure the company's engineering efforts align with strategic objectives. You will also provide leadership and guidance to the engineering team supporting 24/7 manufacturing and facility operations.

The Senior Manager Process Engineering joins the Facilities & Engineering (F&E) group reporting to the Facilities & Engineering (F&E) Director, partnering closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. This role develops domain expertise to support operations upon start‑up, focusing on Process engineering and plant equipment as well as hiring and training the staff required to support startup and operations.

• Site design, construction, start‑up, and operational readiness.
• Execute and guide the commissioning and qualification of process equipment in alignment with GMP requirements, working in partnership with global engineering during site installation. Ensure their operational capability aligns with manufacturing requirements and GMP regulation and on‑time project delivery.
• Ensure systems are installed, operating safely, and comply with pertinent environmental health/safety practice, rules and regulations.
• Perform engineering assessments for plant equipment operations, implementing equipment modifications, and supporting engineering runs in support of new product/technology introductions as required.
• Provide system ownership for process equipment typically used in biologics manufacturing, including downstream purification (e.g., chromatography and viral filtration skids, UFDF), and CIP/SIP skids.
• Lead a team of Process Engineering professionals and serve as the main point of contact for Process and equipment engineering function.
• Establish clear expectations and priorities for staff. Encourage a culture of continuous improvement, partnership, and knowledge sharing. Provide development opportunities, feedback, and actively listen to staff.
• Effectively collaborate with key customers and support groups (e.g., Manufacturing, Quality, Process Development, Maintenance, network partners).
• Work with original equipment manufacturers for breakdown and planned maintenance of process equipment.
• Work with integrated service providers for day‑to‑day operational activities, breakdown and planned maintenance.
• Lead identifying and implementing engineering‑based improvements or upgrades to process equipment systems. This may include developing business cases for improvements, identifying design requirements, and translating these requirements into process equipment/system design, specifications, and supporting the construction, startup, and validation of equipment.
• Develop equipment maintenance programs, ensure the availability of spare parts, and coordinate maintenance activities to ensure systems are in proper working order.
• Ensure plant readiness and quality and regulatory compliance for internal audits, external agency audits, and partner audits for the process equipment.
• Provide system guidance to identify performance risks and implement risk reduction strategies.
• Provide technical support to troubleshoot, identify and resolve process and system issues as needed.
• Provide strategic, tactical management, and leadership to ensure 24x7 day‑to‑day reliability of plant operations.
• Participate in the budgeting process for process engineering, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.
• Travel: approximately 10% domestic/international travel.

• High school diploma / GED and 12 years of engineering experience OR
• Associate’s degree and 10 years of engineering experience OR
• Bachelor’s degree and 8 years of engineering experience OR
• Master’s degree and 6 years of engineering experience OR
• Doctorate degree and 2 years of engineering experience.
• Minimum of 2 years of experience directly…