Senior Engineer- 35392

Important Notice: This opportunity is available only direct individuals' candidates. Third party contractor submissions, staffing, vendors, and Corp-to- Corp (C2C) arrangements will not be considered for this position.

Work Schedule: On-site | Administrative Shift (Must be available to work different shifts and weekends based on business needs)

Contract Duration: 5 months

Position Summary

Our client is seeking an experienced Senior Engineer to provide technical leadership in process optimization, operational troubleshooting, manufacturing support, pilot plant activities, and capital projects.

The selected candidate will independently lead complex engineering initiatives, apply advanced engineering principles to major system modifications, and support process improvements in a highly regulated manufacturing environment. This role requires strong analytical skills, technical expertise, and the ability to collaborate across multiple functional areas.

Key Responsibilities

Engineering & Technical Leadership

• Lead complex engineering assignments requiring the development of new or improved engineering techniques and procedures.
• Develop engineering policies and procedures that impact multiple organizational units.
• Provide technical leadership and guidance to engineers, associates, and technicians on both daily operations and project activities.
• Apply advanced engineering principles to process optimization, troubleshooting, and system improvements.
• Serve as a recognized technical expert in at least one engineering discipline and establish methodologies for that area.
• Plan, organize, analyze, and interpret engineering data to support operational improvements and project execution.
• Develop innovative technical solutions for complex engineering challenges.
• Collaborate with Manufacturing, Process Development, Research, Utilities, Facilities, Validation, and Quality teams to define requirements for system and facility modifications.
• Partner with project managers to deliver engineering projects on schedule, within budget, and in compliance with quality standards.
• Coordinate the work of consultants, architects, and external engineering firms.
• Develop departmental and project budgets for multidisciplinary engineering initiatives.

Process & Manufacturing Support

• Own Change Controls related to manufacturing process changes.
• Support deviation investigations throughout the entire lifecycle, including:
• Root Cause Analysis (RCA)
• Identification of Corrective and Preventive Actions (CAPA)
• Presenting findings during regulatory inspections
• Support risk assessments and microbial assessment evaluations.
• Lead commercial campaign readiness activities while coordinating with cross-functional teams.
• Provide manufacturing floor support and troubleshooting as needed.
• Design, coordinate, and support execution of:
• Functional testing
• Water testing
• Campaign readiness activities
• Generate technical protocols when required.
• Support the creation and revision of Master Batch Records (MBRs).
• Evaluate process, automation, and equipment modifications, including implementation of special projects.
• Author, revise, and approve Standard Operating Procedures (SOPs) and manufacturing procedures while serving as document owner.
• Monitor process performance, analyze operational data, and implement process improvement initiatives.
• Complete CAPA applicability assessments for other manufacturing sites.
• Assess new or modified Bills of Materials (BOMs).
• Provide technical guidance and mentoring within areas of engineering expertise.
• Assist in developing technical training materials.
• Deliver training on scientific and technical process topics.
• Collaborate effectively with Manufacturing, Quality, Process Development, Validation, and Technical Operations teams.
• Communicate technical information clearly to both technical and management audiences.

Minimum Qualifications

One of the following is required:

• Doctorate in Engineering; or
• Master's degree in Engineering with at least 2 years of engineering experience; or
• Bachelor's degree in Engineering with at least 4 years of engineering experience.

Required Qualifications

• Working knowledge of pharmaceutical or biotechnology manufacturing processes.
• Experience working in highly regulated GMP environments.
• Knowledge of validation processes and protocol execution.
• Familiarity with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP).
• Ability to apply engineering principles to manufacturing operations.
• Experience operating specialized laboratory equipment and computer systems.
• Strong analytical and technical problem-solving skills.
• Excellent organizational and time management abilities.
• Ability to manage multiple priorities and projects simultaneously.
• Strong written and verbal communication skills in both English and Spanish.

Technical Skills

Candidates should demonstrate experience in:

• Process optimization
• Engineering problem-solving
• Validation protocol development and execution
• Technical report writing
• Technical presentations
• Project scheduling and coordination
• Process monitoring
• Scientific investigations
• Analytical troubleshooting
• Documentation management
• Computer proficiency
• Collaboration across multidisciplinary teams
• Contractor and vendor management
• Leadership and team development
• Budget development and financial awareness
• Negotiation and facilitation
• Project management and follow-up

Preferred Qualifications

• Engineering experience within the biotechnology or pharmaceutical industry.
• Extensive knowledge of bioprocessing unit operations.
• Strong experience with Root Cause Analysis methodologies, including:
• Fishbone Diagram
• 5 Whys
• Six Boxes
• Familiarity with Lean Manufacturing principles.
• Experience collaborating with Manufacturing, Quality, Process Development, and Technical Operations teams.
• Strong technical writing and presentation skills.
• Experience with the following systems:
• TrackWise
• Spotfire
• CDOCS
• Process monitoring platforms
• Excellent communication skills in both English and Spanish.