Sr. Engineer, Manufacturing - Guayama, Puerto Rico - Baxter
Descripción
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.
Your role at Baxter:
This role main responsibility is to calculate and monitor chemical plant yield and mass balance. This role is responsible for evaluation and implementation of process and/or system optimization for yields, plan throughput, quality and cost reduction. Also, this role is responsible for process validations (IQ/OQ/PQ). Continuous Process Verification and reliability of the process/equipment.
Your team:
We develop quality products with the patient in mind, so our marketing efforts are also patient centric. That means you can be proud of our work and the value we provide to people every day.
As a large, multinational organization, you could expand your knowledge through collaboration with a variety of individuals, exposure to different facets of our portfolio, and an encouraging leadership team that encourages ongoing development.
What you'll be doing:
-This role is responsible for reactions and columns performance.
-Support the mass balance data to ensure all the data is entered correctly in the system.
-Support the process performance (Yield, Overheads, Finished Goods, Work in process). Support the evaluation and the actions to be taken to improve them.
-Evaluate process performance end of month results and determine the actions required for improvement. Complete the monthly financial explanations.
-Revise and/ or create the plant documents such as MBRs, SOPs, Manuals, special protocols, PFMEA and any other document and provide training to the manufacturing personnel.
-Perform improvements and project following the change control system. Complete Green and Black Belts projects as well other initiatives in coordination with other areas such as R&D and Engineering
-Perform Continued Process Verification (CPV) of the process, validation (IQ/OQ/PQ) assigned and complete the instrument critically classification as deemed necessary.
-Generate NCRs related to manufacturing process and complete CAPA as required. Perform the Annual Product Report (APR) data as scheduled.
-Perform and support equipment troubleshooting following the problem-solving tools, using the Delta V System and P&IDs, provide recommendations and support reliability initiatives.
-Participate in the PSM / RMP meetings and complete the commitments as required.
What you'll bring:
Education: Bachelor's Degree in Engineering or Science Related Field
Job Experience: Three (3) to five (5) years experience
Qualifications
Language: Fully Bilingual – written and spoken English and Spanish
Regulations: Strong cGMP knowledge, 21CFR Parts 210 & 211, ICH Q7A, Eudralex and other applicable to API & FG Anesthesia; Strong OSHA & EHSS knowledge
Technical Qualifications and Other Background
Computer literate (Word, Excel, Power Point)
Knowledgeable on chemical processes and equipment (Chemical Plants)
Strong analytical and problem-solving skills
Project management knowledge/skills
-Technical writing & reporting skills
Knowledgeable on process & equipment validations
-Able to interpret and convert units of measure such as temperature, pressure, flow, area, mass, distance, volume and other
-Ability to understand technical drawings
-Basic machine/software platform/equipment troubleshooting skills
-Lean Six Sigma Tools knowledge and expertise
-Strong negotiation skills
-Knowledge of TPM (Total Predictive Maintenance) and TPR (Total Process Reliability)