Senior Engineer

The Senior Engineer independently leads and directs the characterization of process optimization strategies and troubleshooting of operational issues across manufacturing, operations, pilot plant, and capital project environments. This role applies advanced and diverse engineering principles to design and implement major system modifications, experiments, and process or capital projects. The Senior Engineer develops, organizes, analyzes, and presents technical interpretations for complex operational issues and engineering initiatives of significant scope.

KEY RESPONSIBILITIES

• Complete complex or novel engineering assignments requiring development of new or improved techniques, methodologies, and procedures.
• Apply mature engineering knowledge to plan, design, and execute projects of varying complexity.
• Serve as a peer‑recognized specialist in at least one engineering technology area, determining methodologies and best practices.
• Apply engineering principles both within and outside primary discipline to support a broad variety of assignments.
• Develop technical solutions to complex problems requiring ingenuity, creativity, and scientific/engineering judgment.
• Lead troubleshooting of operational issues in manufacturing, pilot plant, utilities, facilities, and capital project environments.
• Evaluate equipment failures, performance issues, maintenance history, and operating conditions to determine impact on product, process, quality, and equipment qualified state.
• Provide technical support for deviations, investigations, CAPAs, change controls, risk assessments, and post‑inspection commitments.
• Partner with Manufacturing, Process Development, Quality, Maintenance, Automation, Facilities, and Validation to develop requirements and recommendations for highly complex system or facility modifications.
• Collaborate with external vendors, architects, consultants, and engineering firms to develop standard design documents and technical specifications.
• Review and interpret engineering drawings, vendor documentation, equipment manuals, calibration records, and historical performance data.
• Work with project managers to complete engineering projects within schedule, budget, and quality constraints.
• Develop departmental or project budgets involving multiple engineering disciplines.
• Coordinate and supervise the work of engineers, associates, and technicians on both ongoing and project‑specific assignments.
• Manage contractors and vendors, ensuring alignment with project goals and compliance requirements.
• Demonstrate comprehensive understanding of validation protocol execution requirements.
• Support validation activities for new equipment installations, process changes, and system modifications.
• Ensure engineering assessments and documentation meet cGMP, GLP, GDP, and regulatory expectations.
• Prepare, review, and approve technical reports, engineering assessments, equipment evaluations, and technical justifications.

CORE COMPETENCIES & SKILLS

• Working knowledge of pharmaceutical/biotech processes.
• Strong familiarity with validation processes and regulated documentation requirements.
• Ability to interpret and apply GLPs, GMPs, and engineering science to production environments.
• Ability to operate specialized laboratory and manufacturing equipment.
• Strong analytical problem‑solving skills and applied engineering judgment.
• Excellent technical report writing and verbal communication skills.
• Proficiency in technical presentations, personal organization, and validation protocol writing.
• Ability to manage change, handle multiple projects, and interact effectively across diverse communication styles.
• Expertise in at least three engineering technology areas.
• Working knowledge of financial analysis tools.
• Strong leadership, facilitation, negotiation, conflict resolution, and team‑building skills.
• Ability to delegate and manage project work of others.

EDUCATION REQUIREMENTS

One of the following is required:

• Doctorate, OR
• Master’s degree + 2 years of Engineering experience, OR
• Bachelor’s degree in Engineering + 4 years of Engineering experience.

Preferred:

• Bachelor’s degree in Engineering + 5 years of Engineering experience.

PREFERRED QUALIFICATIONS

• Experience performing technical assessments of equipment in regulated pharmaceutical or biotechnology environments.
• Experience with packaging equipment, equipment design, and engineering project execution.
• Knowledge of equipment lifecycle management, reliability, and maintenance strategies.
• Experience supporting deviations, CAPAs, change controls, and risk assessments.
• Strong technical writing skills with ability to produce clear, factual, inspection‑ready documentation.
• Experience with purification, fermentation, utilities, or pharmaceutical manufacturing systems.
• Strong field presence and willingness to inspect equipment and verify operating conditions.
• Knowledge of validation processes, equipment qualification, and engineering documentation.
• Experience in medical device or pharmaceutical manufacturing environments.
• Ability to collaborate effectively with cross‑functional teams and external vendors.

• Contract position
• Shift Requirements
• Standard schedule: 8:00 AM – 5:00 PM
• Overtime may be required based on business needs.