Sr Engineer-Assembly / Devices

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.

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 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
• COMPETENCIES/SKILLS
• 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

Comprehensive understanding of validation protocol execution requirements.

Basic technical presentationso Personal Organizationo Validation Protocol Writing

Dealing with and managing changeo Technical (Equipment Specific)

Requirements

• Doctorate OR
• Masters + 2 years of Engineering experience OR
• Bachelors in Engineering + 4 years of Engineering experience.

Preferred Qualifications:

• C&Q Strategy & Planning: Define system boundaries and identify direct/indirect impact systems.
• Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.
• Commissioning Activities: Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning.
• Review and approve commissioning documentation and test results.
• Qualification Execution (IQ/OQ/PQ): Author, review, and approve qualification protocols (IQ, OQ, PQ).
• Ensure traceability from User Requirements Specifications (URS) through testing.
• Execute or oversee protocol execution and ensure proper documentation of results.
• Documentation & Compliance: Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal standards.
• Support data integrity and ALCOA+ principles throughout qualification activities.
• Risk Management & Change Control: Lead and document risk assessments related to system qualification.
• Evaluate and manage change controls impacting validated systems.
• Assess impact of deviations and implement corrective and preventive actions (CAPA).