Sr. Engineer- 35630

CIS International LLC; Juncos (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

CIS International LLC seeks an experienced Design/Commissioning Engineer to lead qualification strategies and oversee IQ/OQ/PQ across GMP biotech environments. You will drive risk assessments for system qualification and coordinate with Engineering, Validation, QA, Manufacturing and Supply Chain to deliver complex projects.

Responsibilities include developing documentation, validating systems, and mentoring junior engineers.

Qualifications

• Doctorate or Master’s degree with 2+ years engineering experience.
• Bachelor’s degree in Engineering with 4+ years engineering experience.
• Experience in validated pharmaceutical/biotech environments and regulated documentation.

Responsibilities

• Lead the design, execution and review of qualification protocols (IQ/OQ/PQ).
• Develop and implement commissioning & qualification strategies aligned with project needs.
• Coordinate with Engineering, Validation, QA, Manufacturing and Supply Chain teams.
• Ensure GMP/GLP compliance and ALCOA+ data integrity in all QC/documentation.
• Mentor junior engineers and provide technical guidance across projects.

Skills

Pharma/biotech processes

Validation processes

Documentation in regulated env

GLPs and GMPs

Engineering in production

Problem solving

Technical report writing

Verbal communication

Education

Doctorate

Masters + 2 years eng exp

Bachelors in Engineering

Job description

• Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.

SUMMARY:

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:

General:

• 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.

*Other functions may be assigned

Design Engineering:

• 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.

EDUCATION:

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

PREFERRED QUALIFICATIONS:

1. C&Q Strategy & Planning

• 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.

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 activities.
• 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 User Requirements Specifications (URS) through testing.
• Execute or oversee protocol execution and ensure proper documentation of results.

4. Documentation & Compliance

• 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.

5. 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).

6. Cross-functional Coordination

• 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.

7. Characterization Process

• Develop the characterization protocols.
• Execute the characterization activities.
• Develop and review the characterization reports.

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.

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