Engineer II, Manufacturing Science and Technology

Support all functions of the pharmaceutical supply chain for products throughout their lifecycle. This includes products in process development (pre-commercialization) and process optimization (post-commercialization). Ensure products are developed and manufactured per current regulatory requirements and industry standards (cGMP’s, QbD, ICH, etc.). Work cross-functionally to ensure raw materials and components are available and product is manufactured within established timelines.  

The Engineer II will demonstrate a broad understanding of the manufacturing unit operations, equipment, and supply chain from drug product manufacturing (which includes formulation, filling, and manual inspection) through packaging and how the different departments within the organization interact with each other. The Engineer II will assist with planning and execution of routine technical assignments and demonstrate a firm understanding of relevant pharmaceutical regulations related to cGMP manufacturing.

Support manufacturing operations at Contract sites (CMOs, etc.).  Responsibilities include, but may not be limited to:

• Assists in planning development and clinical production, which includes forecasting, budgeting, and scheduling
• Evaluate alternate technologies and equipment for manufacturing process improvement
• Supports colleagues in routine, day-to-day manufacturing activities to ensure product is manufactured on time per the required timelines
• Provides on-site support at Contract sites (CMOs, etc.) during critical  manufacturing activities
• Helps with logistics activities such as quotes, purchase orders, invoices, inventory management and shipment of product
• Frequently interacts with other functional peer group managers and CMOs to support manufacturing activities
• Accurately collects / performs data mining and appropriately records / trends observations
• Writing technical protocols and reports for process engineering studies
• Aids in the review of GMP batch records, work instructions, SOPs, deviations, CAPAs, or other required documents for cGMP operations
• Collaborate with other functions such as Product Development, Device Development, Commercial Manufacturing, Quality Assurance, Quality Control, Regulatory and Finance

• Bachelor’s/Master’s degree required in Engineering or relevant Supply Chain, Scientific, or equivalent degree with minimum 5+ years (Engineer II) of experience working in pharmaceuticals
• Minimum 3 to 5 years of experience in a GMP pharmaceutical/biopharmaceutical environment with knowledge of aseptic processing and sterile drug product manufacturing
• Must have strong computer skills (including all Microsoft Office), Analytics, Technical Writing, Scheduling, Inventory Management
• Skills preferred: Data Management, Project Management, Manufacturing/Supply Chain background, Technical Transfer/Process Validation, Problem Solving, Communication (written and verbal), Organizational, Analytical, and Presentation skills
• Competencies:  Teamwork & Collaboration, Attention to Detail, Self-Starter, Adaptability, Professionalism, Accountability
• Working Conditions:
  • Position may require periodic evening and weekend work, as necessary to fulfill obligations.
  • Travel may be required up to 25% at times to CMOs and CSPs location. Periodic overnight travel may occur for work.
  • If On-Site: This is a hybrid role based in Xeris’ Chicago office and requires a minimum of three days per week in the office. On-site requirement may change at management’s discretion.
  • If Remote: The nature of this role requires frequent travel; thus, the incumbent must reside within reasonable proximity to a major international airport to ease travel time/expense to the airport and to reduce frequency of travel requiring layovers. Travel expectations would increase up to 30% to include the above locations as well as regular travel to our Corporate Office.

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As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.

The anticipated base salary range for this position is $70,000 to $120,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process

NOTE:  This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.