Staff Engineer, Process Systems

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee and direct all engineering functions related to advanced biotechnological systems, encompassing utilities, process equipment, automation systems, and facilities.

• Address significant and distinctive challenges where situational or data analysis necessitates the assessment of intangible factors, potentially influencing future concepts, products, or technologies.

• Evaluate and authorize process equipment documentation, including protocols, test plans, reports, and other deliverables, ensuring compliance with company standards and regulatory guidelines.

• Perform detailed risk assessments and develop strategies to validate and enhance critical process parameters in accordance with industry standards and regulatory frameworks.

• Conduct thorough system and equipment inspections, which include Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ), ensuring accuracy and compliance.

• Spearhead engineering feasibility studies and conceptual & basic design efforts for projects spanning various products and locations.

• Lead validation efforts to ensure adherence to cGMP, FDA, EMA, and other relevant regulatory bodies.

• Supervise the review and endorsement of validation protocols, plans, and reports, ensuring consistency with industry standards and the establishment of robust, reliable processes.

• Assess complex validation data to uncover critical trends, continually enhancing the reliability, efficiency, and compliance of validated systems.

• Establish formal networks with key decision-makers and act as an external representative for the organization in engagements with CDMO and supplier partners.

• Manage project activities and teams involved in cross-functional engineering projects from inception to completion, balancing intricate timelines, budget limitations, resource distribution, and quality benchmarks.

• Collaborate effectively with senior project managers, cross-functional teams, contractors, and external vendors to coordinate, prioritize, and implement engineering initiatives.

• Provide strategic technical direction and cultivate a culture of innovation, collaboration, and ongoing improvement.

• Ensure that project deliverables are achieved within defined scope and timelines, while maintaining an emphasis on compliance, quality, and cost-efficiency.

⛳️ Requirements

• Bachelor’s or Master’s degree in Engineering (Chemical, Mechanical, Biomedical, or related field) or Biotechnology, with at least 10+ years of experience in Bioprocessing/Process Engineering within the biotechnology, pharmaceutical, or biopharmaceutical sector. Alternative combinations of education and/or experience may be taken into account.

• Demonstrated leadership experience in overseeing teams and large-scale Capex projects, including utilities, process equipment, and automation systems.

• Comprehensive understanding of biopharmaceutical manufacturing processes and equipment, particularly DCS, ISA-88 batch process control, and PLC-based control systems.

• Proven track record in managing engineering tasks for large-scale or complex facilities under stringent timelines and budgetary constraints.

• Proficient knowledge of drug product manufacturing and related unit operations, including compounding, automated visual inspection, assembly, labeling, and packaging.

• In-depth expertise in cGMP, FDA, EMA, ICH guidelines, and other international regulatory standards.

• Strong grasp of bioprocessing, encompassing upstream and downstream processing, aseptic processing, and sterilization methods.

• Advanced skills in statistical analysis, risk assessment methodologies, and best practices for process validation.

• Extensive experience with quality management systems (QMS) and electronic documentation systems to uphold compliant documentation and facilitate audit activities.

• Ability to assist and, when necessary, undertake a variety of broader engineering functions and activities, including project management, process optimization, automation, and utilities engineering.

• Exceptional leadership, communication, and interpersonal skills, with the capability to influence at all organizational levels and with external partners.

• Strong analytical thinking, decision-making, and problem-solving skills, particularly in high-pressure scenarios.

• Capacity to prioritize and manage multiple intricate projects, balancing competing demands while ensuring regulatory compliance and organizational objectives.

• Excellent mentoring and coaching skills, promoting a culture of innovation and continuous enhancement.

🏝️ Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component.