Sr. Engineer- 35333 (C&Q/ Validation)

CIS International•Juncos, PR

1d•Onsite

About The Position

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.

Requirements

Doctorate or Masters + 2 years of Engineering experience.
Bachelors in Engineering + 4 years of Engineering experience.
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.
Problem solving and applied engineering.
Basic technical report writing
Verbal communication
Comprehensive understanding of validation protocol execution requirements.
Basic technical presentations
Personal Organization
Validation Protocol Writing
Dealing with and managing change
Technical (Equipment Specific)
Analytical Problem Solving
Computer Literacy
Specialized equipment/process expertise.
In-depth knowledge of validation processes and requirements as applied to new equipment installations.
Interacts effectively with variety of communication and working styles.
Ability to independently determine when additional internal resources are required to solve problems.
Ability to handle multiple projects at one time.
Schedule development
Facilitation
Collaboration
Basic project management
Completion and follow-up
Established expertise in at least 3 separate areas of engineering technology.
Ability to independently determine when additional external resources are required to solve problems.
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope.
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Working knowledge of financial analysis tools.
Ability to delegate and manage the project work of others.
Negotiation, persuasion and facilitation
Collaboration
Project cost development
Conflict Resolution
Leadership and teambuilding
Management of contractors and vendors

Nice To Haves

C&Q Strategy & Planning
Commissioning Activities
Qualification Execution (IQ/OQ/PQ)
Documentation & Compliance
Risk Management & Change Control
Cross-functional Coordination
Characterization Process

Responsibilities

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.
Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
Define system boundaries and identify direct/indirect impact systems.
Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.
Develop C&Q plans, schedules, and resource forecasting.
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 activities.
Review and approve commissioning documentation and test results.
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.
Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards.
Maintain document lifecycle within electronic systems.
Support data integrity and ALCOA+ principles throughout qualification activities.
Prepare and support validation summary reports.
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).
Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.
Interface with system owners and technical authorities.
Provide technical guidance and mentorship to junior engineers and project team members.
Support project meetings, status reporting, and stakeholder communication.
Develop the characterization protocols.
Execute the characterization activities.
Develop and review the characterization reports.