Rico Callaway
Biopharmaceutical
Frederick,MD
Summary
Dynamic and results-driven Process Engineer, CQV/CSV Specialist, and Quality Systems Consultant with over 20 years of leadership experience, including service as a U.S. Marine veteran. Expert in cell therapy, cell culture, and upstream bio process manufacturing, with proven success implementing automation, validation, and compliance programs in GMP/FDA-regulated environments. As founder of Callaway Solutions LLC, Rico blends technical precision with human leadership, leveraging his background as a certified life coach to guide teams through change, foster collaboration, and align people and processes with organizational goals. Recognized for delivering measurable results while leading with clarity, integrity, and a people-first mindset.
Overview
20
20
years of professional experience
10
10
Certifications
Work History
Life Coach
Callaway Solutions Life Coaching
01.2025 - Current
- Provide one-on-one coaching sessions to clients, helping them clarify goals, overcome obstacles, and achieve personal and professional milestones.
- Develop customized action plans and accountability strategies tailored to individual client needs and goals.
- Empower clients to identify limiting beliefs and reframe negative thought patterns using techniques rooted in positive psychology and cognitive behavioral tools.
- Maintained a 90%+ client retention rate through consistent, results-driven coaching and trust-based relationships.
- Design and deliver group coaching workshops and webinars on topics such as goal setting, stress management, and effective communication.
- Collaborate with other professionals (therapists, career advisors, wellness experts) to provide holistic support to clients when needed.
- Demonstrate cultural sensitivity and emotional intelligence when coaching clients across various life stages and identities.
Quality Engineer
PII-Supervisor
01.2023
- Supervised day-to-day quality operations and provided technical leadership in a GMP manufacturing environment focused on aseptic processing, component preparation, and packaging.
- Directed a team of quality inspectors and technicians, ensuring real-time quality oversight and compliance with FDA, ISO 13485, and EU Annex 1 requirements.
- Led investigation reviews, CAPA implementation, and deviation closure with a focus on root-cause accuracy and prevention of recurrence.
- Supported process validation (IQ/OQ/PQ) and product qualification activities, ensuring adherence to internal quality systems and client specifications.
- Monitored environmental and process trends to identify emerging issues, improving data integrity and inspection readiness.
- Collaborated cross-functionally with Manufacturing, Engineering, and Supply Chain to drive process improvements and enhance product reliability.
- Facilitated GMP and quality training to increase team ownership and compliance culture within operations.
- Contributed to continuous improvement initiatives, reducing defect rates and improving first-pass yield through Lean/Six Sigma methodologies.
Aseptic Processing Engineering & Coaching (Contractor)
Pfizer
12.2024 - 01.2025
- Provide engineering oversight and technical leadership for aseptic filling, formulation, and cleanroom operations, ensuring compliance with Annex 1, FDA, and cGMP requirements.
- Lead and support the design, qualification, and validation of aseptic processes, cleanrooms, isolators, RABS, and equipment (IQ/OQ/PQ, PPQ).
- Partner with Quality, Validation, and Operations to assess and close Annex 1 gaps and strengthen the facility’s Contamination Control Strategy (CCS).
- Drive risk-based decision making, utilizing tools such as FMEA, Fishbone, 5 Why’s, and CAPA to reduce deviation recurrence and enhance aseptic discipline.
- Conduct coaching sessions with production personnel, focusing on aseptic behaviors, gowning practices, and contamination prevention mindset.
- Develop and deliver training modules that align operational excellence with regulatory expectations.
- Perform process investigations, assess deviation impact, and author technical reports with a focus on prevention and knowledge transfer.
- Collaborate with external partners/CMOs to provide technical and quality oversight on aseptic operations, validation, and inspection readiness.
- Lead continuous improvement initiatives related to process efficiency, cleanroom optimization, and operator engagement.
- Serve as a subject matter expert (SME) during regulatory audits and client inspections.
SR. Quality Specialist (Contractor)
Oxford Biomedica Solutions
04.2023 - 07.2023
- Provide quality oversight for CDMO/CMO activities, including technology transfer, aseptic processing, PPQ, and commercial production and PIP.
- Review and approve batch records, deviations, CAPAs, and change controls, ensuring timely closure and regulatory compliance.
- Conduct Annex 1 gap assessments and implement contamination control strategies (CCS) across manufacturing and QC environments.
- Participate in or lead client and regulatory inspections, providing SME-level support for aseptic operations and GMP documentation.
- Collaborate with cross-functional teams (Engineering, Validation, Manufacturing, and Supply Chain) to support compliant process startup and qualification at new facilities.
- Author, review, and approve quality documents including SOPs, validation protocols, and technical reports.
- Support supplier and CMO qualification audits, evaluating performance, compliance history, and risk mitigation plans.
- Perform risk assessments (FMEA, 5 Why’s, Fishbone) to proactively identify and correct quality system and manufacturing gaps.
- Lead continuous improvement initiatives, leveraging Lean and Six Sigma principles to reduce deviations, improve cycle times, and enhance right-first-time metrics.
- Coach and mentor operational teams in GMP behaviors, deviation investigation quality, and contamination prevention.
QA Investigation Reviewer & Approver Quality Leader
Johnson & Johnson
08.2022 - 01.2023
- Led quality review and approval of deviations, CAPAs, and change controls within aseptic and biologics manufacturing environments, ensuring compliance with GMP, Annex 1, and FDA 21 CFR Parts 210/211.
- Provided subject-matter expert expertise in root-cause investigations, risk assessments (5 Why’s, FMEA), and CAPA effectiveness verification to maintain product and process integrity.
- Partnered cross-functionally with Manufacturing, Validation, and Engineering to drive timely closure of quality events and improve investigation quality through coaching and training.
- Supported development and refinement of Contamination Control Strategies (CCS) to align site practices with the 2022 Annex 1 revision.
- Acted as QA lead during internal audits and inspection readiness activities, ensuring consistency and traceability of deviation and CAPA documentation across QMS platforms (Veeva/TrackWise).
- Championed continuous-improvement initiatives that enhanced investigation clarity, reduced repeat deviations, and strengthened aseptic process discipline.
SR. Manufacturing Engineer
Lentigen/Miltenyi
08.2021 - 08.2022
- Led manufacturing engineering and process optimization for upstream cell culture and cell therapy operations within CDMO and CMO environments, supporting both clinical and commercial production.
- Provided technical leadership for bioreactor scale-up and transfer of cell-based processes (2 L – 2,000 L single-use systems), ensuring alignment with GMP and Annex 1 standards.
- Supported technology transfer and process validation (PPQ, CQV) activities for client programs, partnering with Quality, MSAT, and Validation teams.
- Authored and executed equipment qualification protocols (IQ/OQ/PQ), ensuring readiness and traceability of critical manufacturing assets.
- Served as engineering SME for contamination control, cleanroom operations, and automation integration within upstream production suites.
- Drove continuous improvement initiatives, using Lean/Six Sigma and root-cause tools (FMEA, 5 Why’s, Fishbone) to increase yield, reduce deviations, and enhance process robustness.
- Collaborated with external CDMO clients to resolve technical challenges, support audits, and maintain quality and regulatory compliance.
- Reviewed and approved manufacturing documentation, batch records, and deviation investigations to ensure process integrity.
- Mentored operations staff on bioreactor operation, aseptic technique, and process troubleshooting to strengthen in-house technical capability.
Senior Quality Engineer
Catalent Pharma
11.2020 - 01.2022
- Provided quality engineering leadership in a global CDMO manufacturing environment, supporting aseptic processing, biologics, and sterile product operations.
- Led root cause investigations, CAPA implementation, and risk assessments (FMEA, 5 Why’s, Fishbone) to resolve deviations and strengthen quality system performance.
- Supported equipment qualification (IQ/OQ/PQ), process validation (PPQ), and change control activities in alignment with FDA 21 CFR 210/211 and EU Annex 1 standards.
- Partnered cross-functionally with Manufacturing, Validation, and MS&T to drive right-first-time production, reduce deviations, and improve process robustness.
- Served as QA/QE SME during audits and regulatory inspections, providing responses and documentation supporting site readiness and compliance.
- Developed and reviewed SOPs, validation protocols, and engineering documentation to ensure consistency with QMS and project deliverables.
- Championed continuous improvement projects using Lean and Six Sigma methodologies, improving deviation closure rate and equipment reliability.
- Mentored production and quality staff on investigation best practices, risk assessment, and GMP documentation integrity.
Quality & Logistics Engineer
Novavax
09.2020 - 01.2021
- Ensured strict adherence to standards and safety regulations, maintaining high-quality benchmarks.
- Identified and implemented quality improvement factors to enhance operational efficiency and drive continuous process improvement.
- Developed and executed CAPA and Change Control strategies. Maintained regulatory compliance, including FDA and DEA inspections.
- Performed quality assurance activities on the production floor, focusing on real-time batch record reviews.
- Demonstrated proficiency in SAP, QMS, Veeva, Vault, Trackwise, and LIMS, enhancing quality management processes.
- Led investigations, including root cause analysis, to assess and mitigate product impact.
- Documented quality assurance activities and created comprehensive audit reports, by closely liaising with appointed teams for a seamless execution of projects.
- Identified and resolved workflow and production issues, adhering to GDP and CGMP standards.
- Managed all aspects of Aseptic Fill Finish operations, ensuring strict compliance with aseptic gowning procedures.
Upstream Buffer, Cell Culture & Cell Therapy Engineer
AstraZeneca
10.2018 - 09.2020
- Supported upstream manufacturing operations for biologics and cell therapy programs across CDMO/CMO partnerships, focusing on buffer preparation, cell culture expansion, and bioreactor operations.
- Executed buffer formulation, filtration, and sterile transfer processes in compliance with Annex 1, GMP, and ISO 13485 regulations.
- Operated and optimized single-use bioreactors (2 L–2,000 L), supporting scale-up and tech transfer activities between AstraZeneca and contract manufacturing sites.
- Collaborated with Process Development, MSAT, Quality, and external CMO teams to implement process improvements, enhance yields, and ensure sterility assurance.
- Applied Lean Six Sigma and DMAIC methodologies to streamline process steps, reduce cycle time, and enhance consistency across upstream operations.
- Supported equipment qualification (IQ/OQ/PQ) and process validation (PPQ) readiness for client and internal manufacturing programs.
- Ensured alignment with Contamination Control Strategy (CCS) by strengthening aseptic handling, material flow, and cleaning validation practices.
- Authored and reviewed SOPs, batch records, and validation protocols to ensure documentation traceability and regulatory compliance.
- Provided technical coaching to operators and external partners on upstream operations, aseptic connections, and buffer management best practices.
Manufacturing Engineering
Lonza
12.2014 - 01.2015
- Provided engineering and process oversight for powder and liquid media manufacturing supporting biologics and cell therapy production within global CDMO/CMO environments.
- Managed the formulation, mixing, filtration, and sterile transfer of media and buffer solutions in compliance with Annex 1, cGMP, and ISO 13485 standards.
- Supported tech transfer, equipment qualification (IQ/OQ/PQ), and process validation (PPQ) for new client programs and production lines.
- Partnered with MSAT, QA, and Manufacturing teams to optimize preparation processes, improve throughput, and maintain sterility assurance.
- Applied Lean Six Sigma methodologies to reduce downtime, improve mixing uniformity, and enhance batch-to-batch consistency.
- Led root-cause investigations and CAPA execution related to powder dissolution, mixing, and filtration performance.
- Ensured contamination control strategy (CCS) compliance by improving cleaning verification and powder-to-liquid segregation practices.
- Authored and reviewed SOPs, batch records, and technical reports for buffer and media operations in alignment with GMP and client specifications.
- Provided coaching and hands-on training to operators in aseptic media preparation, weighing, and documentation practices.
Education
B.S. - Biological Sciences in Genetics, Cell & Developmental Biology
Arizona State University
Cybersecurity Engineer Program - undefined
NGT Academy
Skills
Vault, EQMS, MES, SAP, Veeva, Trackwise, LIMS, EDMS, Delta V, QMS, Master Control
undefinedCertification
Internal GMP Audit & Role of GMP Auditor | Computer System Validation (CSV) & GAMP 5 | GMP for Medical Devices & FDA 21 CFR Part 820 | Quality Management for Medical Devices – ISO 13485:2016 | Overview of Qualification & Validation | CFRs Part 210 & 211 – cGMPs for Finished Pharmaceuticals | Cleaning Validation Course | Project Management Foundations: Ethics | Lean Six Sigma Yellow Belt | Lean Six Sigma Green Belt – Production
Awards & Recognition
Combat Action Medal, US Marine Corps, 1990 - 1993, Combat Action Veteran, 1989 - 1993, Desert Shield and Desert Storm, 1990 - 1993
Core Competencies
- CQV / CSV Validation
- Process Optimization
- Cell Therapy & Upstream Manufacturing
- Quality Systems (QMS, LIMS, MES)
- Aseptic Processing
- CAPA / Deviation Management
- GMP / GCP / GLP / CGxP
- Change Control
- Automation & Controls
- Risk Assessment / FMEA
- Continuous Improvement
- Leadership & Team Development
Previous Work History
- Quality Control Supervisor, McCormick, 2020
- Quality Assurance Supervisor, Ventura Foods, 2018
- Quality Assurance Supervisor, C-Care, 2018
- Quality Assurance Supervisor, Coca Cola Bottling Co., 2016 - 2018
- Quality Control Supervisor, PepsiCo, 2015 - 2016
- Quality Control, NIH, 2013 - 2014
- SR. Material Management, ThermoFisher, 2010 - 2013
- Private Investigator/Bounty Hunter, 2000 - 2011
- Owner/Operator, Various Businesses, 1997 - 2000
- Marine, Sergeant (highest rank), US Marine Corps, 1989 - 1996
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Life Coach
Callaway Solutions Life Coaching
01.2025 - Current
Aseptic Processing Engineering & Coaching (Contractor)
Pfizer
12.2024 - 01.2025
SR. Quality Specialist (Contractor)
Oxford Biomedica Solutions
04.2023 - 07.2023
Quality Engineer
PII-Supervisor
01.2023
QA Investigation Reviewer & Approver Quality Leader
Johnson & Johnson
08.2022 - 01.2023
SR. Manufacturing Engineer
Lentigen/Miltenyi
08.2021 - 08.2022
Senior Quality Engineer
Catalent Pharma
11.2020 - 01.2022
Quality & Logistics Engineer
Novavax
09.2020 - 01.2021
Upstream Buffer, Cell Culture & Cell Therapy Engineer
AstraZeneca
10.2018 - 09.2020
Manufacturing Engineering
Lonza
12.2014 - 01.2015
Cybersecurity Engineer Program - undefined
NGT Academy
B.S. - Biological Sciences in Genetics, Cell & Developmental Biology
Arizona State University