Process Engineer Time Delivery

Orlando Sifre Senior Process Engineer

adxj4i@r.postjobfree.com https://www.linkedin.com/in/orlando-sifre-ba741045/ 689-***-**** Apopka, FL

Seasoned process engineer with extensive experience orchestrating design, start-up, reliability, and productivity initiatives for improving pharmaceutical and biotechnological manufacturing and development processes. Capable of working within dynamic environments, as well as producing deliverables in tight timeframes under constant pressure. Demonstrate strong analytical, statistical, and creative problem solving skills in applying various operational excellence principles, devising analytic and measurement strategies for projects, eliminating inefficiencies, reducing costs, and developing key performance indicators and future state recommendations. Effective communicator skilled in engaging with cross-functional teams to identify and document current processes, and research best practices to facilitate long-term sustainability. Areas of expertise include:

Strategic Planning

Process Development & Analysis

Quality Assurance

Process Time & Uptime Analysis

Stakeholder Engagement

Technology Assessment

Training & Development

Gap Analysis

Cross-Functional Collaboration

Performance Management

Root Cause Analysis

Automation Specification Review

Cost Optimization

Workstream Management

Data Source Identification

Project Management

Procedure Simplification

Knowledge Transfer

Professional Experience

PharmaBioServ Florida, USA

Senior Technical Consultant for Stada Arzneimittel May 2020 - Current

Delivered key contributions to the technical transfer workstreams of different finish product formulations, including compilation of transfer protocols, revision of product and material specifications, performing as process liaison between sending and receiving sites and identifying project roadblocks to propose technical alternatives and managed progress and requests communications. Facilitated project meetings and workshops to expedite knowledge transfer, custodied transfer timelines and provided guidance for seamless handshake between functional groups contributing to project deliverables, via implementation of project management tools.

Key Accomplishments:

●Prepared transfer documentation via assessment of registered documentation from sending site and customizing it according to new market and required changes ensuring regulatory alignment (European markets)

●Facilitated Risk Assessments using FMEA approach and generated documentation according to recommendations for trial runs and pre validation runs

●Provided project management support of major change proposal and implementation of formulation change

PharmaBioServ Carolina, PR

Project/Process Engineer at Eli Lilly February 2012 – May 2020

Orchestrate front-end engineering development and provided project management support of Fermentation and Isolation Pilot Plant (upstream) expansion projects amounting to $11 million. Provide engineering support to multiple business initiatives including technology enhancements and experimental results assessments. Facilitate process team meetings and root cause finding activities, and prepare write-up and documentation of process investigations events.

Key Accomplishments:

●Ensured full compliance with safety and environmental standards through rigorous effort in conducting risks assessments, process hazard reviews, housekeeping tours, and constructive feedback to fellow workers

●Provided crucial process engineering support to operations group in areas of process optimization, troubleshooting, efficiency improvement, problem prevention, and risk mitigation.

●Implemented process improvement projects for different areas in Purification based on the findings and recommendations of process investigations.

●Resolved numerous equipment and process-related issues in support of downstream steps including reaction, one chromatography, and one tangential flow filtration unit operation.

●Completed PE qualification procedure covering Event Investigation and Change Control Management.

Amgen Juncos, PR

Senior Engineer April 2003 – December 2011

Delivered key contributions to the design, procurement, FAT, and start-up of various upstream and downstream systems. Supervised manufacturing and process support staff through successful start-up and commissioning. Served as reviewer for harvest automation’s requirement and functional documents, as well as system owner for centrifugation, clarification, UF/DF, bulk intermediate filling, freeze systems, and viral filtration.

Key Accomplishments:

●Led the development and implementation of Set to Work strategy in coordination with utilities (clean and dirty) and both upstream and downstream process equipment responsible system owners.

●Monitored and forecasted overall workstream progress towards successful hand-shake with automation workstream.

●Justified overhead from manufacturing staff to provide adequate support to STW efforts during the entire project life cycle, followed by resource management and training.

●Ensured on time delivery of multiple unit operations to automation and validation teams to provide timely knowledge transfer and round-the-clock technical support.

Senior Engineer, Special Projects Owner - 2006 – 2008

Facilitated governance performance evaluation of production teams regarding initiatives and metrics for improving uptime and safeguarding product integrity. Coordinated success rate working sessions, forums, and quarterly summits while serving as liaison with process improvements project and manufacturing teams from both upstream and downstream steps. Monitored and reported progress, and escalated issues to global team. Organized local engagements attended by senior representatives from most major functional areas within site, and managed resource identification activities within the team.

Key Accomplishments:

●Spearheaded the conversion of the Executive Director’s vision into agreed-on boundaries and strategic objectives.

●Influenced teams towards the adoption and standardization of uptime and success rate metrics.

●Aligned site implementation activities in accordance with operational standards requirements.

●Sought sponsorship from site leadership for identifying and pursuing risk mitigation opportunities.

Merck Barceloneta, PR

Facilitator of Productivity System, Pharm Technical Operations January 2002 – March 2003

Performed assessment of various processes including the manufacturing areas of tablets and capsules.

Key Accomplishments:

●Completed the implementation of projects via change procedures and validation, which generated substantial financial benefits including yield improvement, cost avoidance, and capacity increase.

●Formulated new tracking tools for more effective project analysis and financial assessment.

Additional work experience at Merck as Senior Staff Engineer for Bulk Technical Operations.

Education & Credentials

Master of Engineering, Chemical Engineering - 2004

UNIVERSITY OF PUERTO RICO Mayagüez, PR

Bachelor of Science, Biomedical Engineering - 1993

RENSSELAER POLYTECHNIC INSTITUTE Troy, NY

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