Plant Optimization Engineer Jobs in Puerto Rico (NOW HIRING)

Summary of Role:

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

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.* 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

Shift: Administrative

Location: Juncos, PR

Education: Doctorate OR Masters + 2 years of Engineering experience ORBachelors 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.
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.
• 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

This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned