Senior Engineer - Assembly & Devices

Independently provides and/or directs the characterization of process optimization strategies and troubleshooting of operational issues within operations, manufacturing, pilot plant, or capital project environments. Applies advanced and diverse engineering principles to design and implement major system modifications, experiments, and process/capital projects. Develops, organizes, analyzes, and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Functions

• 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 engineers, associates, and technicians on an ongoing and project basis.
• Employ advanced engineering techniques and modifications of advanced techniques within area of expertise.
• Apply engineering principles outside primary discipline to a broad variety of related assignments.
• Serve as a peer‑recognized engineering technology specialist in at least one area, with responsibility for determining methodologies.
• Apply mature engineering knowledge in planning and conducting projects.
• Other functions may be assigned.
• Develop technical solutions to complex problems requiring ingenuity and creativity.
• Collaborate with research, manufacturing, process development, utilities, facilities, quality assurance, and validation to define requirements and recommendations for large or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
• Coordinate work of consultants, architects, and engineering firms in developing standard design documents.
• Develop departmental or project budgets encompassing multiple disciplines.

Skills

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes.
• Familiarity with documentation in highly regulated environments.
• Ability to operate specialized laboratory equipment and computers.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Ability to develop solutions to routine technical problems of limited scope.
• Problem solving and applied engineering.
• Basic technical report writing.
• Strong verbal communication.
• Comprehensive understanding of validation protocol execution requirements.
• Technical presentations, personal organization, validation protocol writing.
• Managing change; equipment‑specific technical expertise.
• Analytical problem solving; computer literacy.
• Specialized equipment/process expertise.
• In‑depth knowledge of validation processes for new equipment installations.
• Ability to interact effectively with diverse communication and working styles.
• Ability to determine when additional internal resources are required.
• Ability to manage multiple projects simultaneously.
• Schedule development, facilitation, collaboration.
• Basic project management, completion, and follow‑up.
• Established expertise in at least three engineering technology areas.
• Ability to determine when external resources are required.
• Ability to solve moderate to highly complex technical problems using scientific and engineering theory.
• Working knowledge of financial analysis tools.
• Ability to delegate and manage project work of others.
• Negotiation, persuasion, facilitation.
• Conflict resolution, leadership, team building.
• Management of contractors and vendors.

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

Preferred Qualifications

1. C&Q Strategy & Planning

• Develop and implement Commissioning & Qualification strategy aligned with project and regulatory requirements.
• Define system boundaries and identify direct/indirect impact systems.
• Lead risk assessments (ISPE Baseline, ASTM E2500).
• Develop C&Q plans, schedules, and resource forecasting.

2. Commissioning Activities

• Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems are installed and operate per design specifications.
• Coordinate with vendors and contractors during startup.
• Review and approve commissioning documentation and test results.

3. Qualification Execution (IQ/OQ/PQ)

• Author, review, and approve qualification protocols (IQ, OQ, PQ).
• Ensure traceability from URS through testing.
• Execute or oversee protocol execution and ensure proper documentation.

4. Documentation & Compliance

• Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal standards.
• Maintain document lifecycle within electronic systems.
• Support data integrity and ALCOA+ principles.
• Prepare and support validation summary reports.

5. Risk Management & Change Control

• Lead and document risk assessments related to system qualification.
• Evaluate and manage change controls impacting validated systems.
• Assess deviations and implement CAPAs.

• 6-month contract with possible extension
  Administrative Shift