Job Description We are seeking a Process Development Principal Scientist to support all phases of inspection project management—from planning and implementation to monitoring, completion, and follow-up—ensuring alignment with goals, timelines, and quality standards.
Responsibilities Lead Process Development related Project Management projects and activities, including timelines and resource allocation.
Collaborate with cross‑functional teams such as manufacturing, process engineering, maintenance, quality assurance, and validation to implement projects.
Support the development of comprehensive business cases, including technical and financial requirements.
Identify potential project risks, schedule changes, or resource constraints and develop and implement solutions to maintain scientific efficiency, quality, and client satisfaction.
Maintain strict adherence to domestic and international regulatory requirements, internal policies, and standard operating procedures throughout the project lifecycle.
Balance competing timelines and priorities, ensuring critical tasks are completed efficiently and project standards for quality and quantity are met.
Provide flexibility to support extended hours, non‑standard shifts, and evolving project demands as needed.
Ensure activities follow cGMP procedures and are documented according to cGMP requirements, including assigned training.
Independently evaluate, select, and apply standard engineering techniques and procedures.
Perform assignments with clear, specific objectives that require investigation of a limited number of variables.
Apply Lean Six Sigma, operational excellence, and continuous improvement principles to assigned projects.
Maintain prompt and regular attendance. Although main working hours are 8:00 am to 5:00 pm, the candidate must be flexible to support non‑standard shift operations in a 24‑hour format, including extended hours and/or weekends as required.
Meet specific project team goals and timelines.
Develop project plans and strategies for implementation in collaboration with project managers and subject‑matter experts.
Qualifications Doctorate (PhD) with at least 2 years of scientific or engineering experience, or Master’s degree with at least 5 years of scientific or engineering experience, or Bachelor’s degree with at least 7 years of scientific or engineering experience.
Bilingual in English and Spanish, both written and spoken.
Equal Employment Opportunity All information will be kept confidential in accordance with EEO guidelines.
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