Sr. Engineer

Weil Group•Juncos, PR

12d

About The Position

We are looking for a visionary Sr. Engineer to lead complex projects, mentor top-tier talent, and drive our technical roadmap. If you thrive in a fast-paced environment and want your code to make a tangible, global impact, this is your place.

Requirements

Master’s degree in Engineering and 2 years of Engineering experience OR Bachelor’s degree in Engineering & 4 years of Engineering experience

Nice To Haves

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
Demonstrated skills in the following areas: Problem solving and applied engineering.
Basic technical report writing
Verbal communication
Comprehensive understanding of validation protocol execution requirements.
Demonstrated Skills in the following areas: 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
Demonstrated Skills in the following areas: 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
Demonstrated Skills in the following areas: Negotiation, persuasion and facilitation
Collaboration
Project cost development
Conflict Resolution
Leadership and teambuilding
Management of contractors and vendors

Responsibilities

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.
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.
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.