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Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity
Job Responsibility:
Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures
Develop engineering policies and procedures that affect multiple organizational units
Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis
Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise
Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area
Application of mature engineering knowledge in planning and conducting projects
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity
Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications
Work with project managers to complete design and engineering projects within schedule, budget and quality constraints
Coordinate the work of consultants, architects and engineering firms on development of standard design documents
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller Project
Willing and able to support non-standard shifts, including nights, weekends, and extended hours
Requirements:
Doctorate OR Masters + 2 years of Engineering experience OR Bachelors in Engineering + 4 years of Engineering experience
GMP knowledge: Strong background in regulated environments with ability to apply GMP in manufacturing and validation
Validation expertise: Experience in drafting, executing, and approving validation
Time pressure filling: Hands-on experience with time pressure filling systems
Technical documentation: Experience in preparing, reviewing, and approving protocols, reports, and strategy presentations
Protocol development: Experienced in designing protocols for complex systems such as filling lines and aseptic processes
Communication skills: Strong written and verbal communication in English and Spanish
Collaboration: Proven experience working with QA, Manufacturing, and Engineering teams during critical activities
Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes
Familiarity with documentation in a highly regulated environment
Ability to operate specialized laboratory equipment and computers as appropriate
Ability to interpret and apply GLPs and GMPs
Ability to apply engineering science to production
Able to develop solutions to routine technical problems of limited scope
What we offer:
medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families
backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions
paid parental leave
paid caregiver leave
variety of training programs
professional development resources
opportunities to participate in mentorship programs