Summary: The Senior Process Engineer will independently lead the characterization, optimization, and troubleshooting of process strategies within operations, manufacturing, pilot plant, or capital projects environments.
This role requires applying advanced engineering principles to implement major system modifications, experiments, and process improvements.
The Senior Process Engineer will also develop, analyze, and present complex engineering project results and provide floor support across production areas in alignment with pharmaceutical regulatory standards.
Responsibilities: General Engineering: Complete complex assignments requiring innovative engineering techniques and improvement methodologies.
Develop engineering policies and procedures impacting multiple departments.
Supervise and review the work of engineers, associates, and technicians, both on an ongoing and project basis.
Apply advanced engineering techniques and knowledge of multidisciplinary engineering principles to a variety of assignments.
Serve as a recognized technical expert within a specific engineering discipline.
Design Engineering: Provide technical solutions to complex problems using ingenuity and creativity.
Collaborate with departments such as research, manufacturing, process development, utilities, quality assurance, and validation to recommend and implement large or complex system and facility modifications.
Work with project managers to ensure design and engineering projects meet schedule, budget, and quality expectations.
Oversee work of consultants, architects, and engineering firms for standard design document development.
Manage project and departmental budgets for area-specific or multi-disciplinary projects.
Experience: Strong background in pharmaceutical or biotech processes.
Working knowledge of validation processes and highly regulated documentation.
Experience with specialized laboratory equipment and computer systems.
Experience with process optimization, equipment troubleshooting, and technical project management.
Familiarity with GLP and GMP compliance.
Key Skills: Advanced problem-solving and applied engineering skills.
Excellent verbal and written communication, including technical report writing and presentation skills.
Proficiency in scheduling, facilitation, collaboration, basic project management, and organizational skills.
Leadership and team-building abilities to manage and motivate cross-functional teams.
Ability to delegate tasks effectively and resolve conflicts when necessary.
Requirements Education: Doctorate in Engineering, OR Master's degree in Engineering with 3+ years of relevant experience, OR Bachelor's degree in Engineering with 5+ years of relevant experience.
Preferred Qualifications: Experience in Packaging and/or Parenterals Inspection.
Floor support experience in the Pharmaceutical or Medical Device industry.
Demonstrated expertise in multiple areas of engineering technology, including analytical problem-solving, project cost development, and equipment-specific knowledge.
Strong skills in communication, collaboration, change management, and technical report writing.
Knowledge of financial analysis tools for budget management and project cost estimation.
Ability to effectively manage contractors and vendors.
Shift: 8 hours | 2nd or 3rd shift