The Role
Leads commissioning, qualification, validation, characterization, and process optimization activities for pharmaceutical manufacturing and packaging systems. Develops C&Q strategies, risk assessments, protocols, schedules, and reports; oversees FAT, SAT, IQ/OQ/PQ, and field commissioning. Ensures GMP, FDA, EMA, data integrity, and documentation compliance while managing change controls, deviations, CAPAs, and cross-functional coordination. Provides technical guidance to junior engineers and supports packaging and material qualification.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Qualifications:
Responsibilities:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- Characterization Process
- Develop the characterization protocols.
- Execute the characterization activities.
- Develop and review the characterization reports
Qualifications:
- Bachelor's degree in Engineering, Packaging Engineering, or a related technical field.
- Experience in packaging and/or engineering within final product manufacturing in the pharmaceutical or biotechnology industry.
- Strong knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Knowledge of pharmaceutical primary and secondary packaging materials, including bottles, labels, trays, lidding materials, leaflets, paperboard, sterile barrier packaging, corrugated materials, and related packaging components.
- Familiarity with distribution testing standards, including ASTM D4169, ASTM, ISO, TAPPI, USP, and EP.
- Strong project management, technical problem-solving, interpersonal, and written/verbal communication skills.
- Ability to work effectively in a cross-functional team environment and adapt to changing business priorities.
- Experience writing test protocols, conducting technical evaluations, and performing packaging or material testing to support technical reports and material/component qualification.
Skills Required
- Bachelor's degree in Engineering, Packaging Engineering, or a related technical field
- Experience in packaging and/or engineering within final product manufacturing in the pharmaceutical or biotechnology industry
- Strong knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
- Knowledge of pharmaceutical primary and secondary packaging materials, including bottles, labels, trays, lidding materials, leaflets, paperboard, sterile barrier packaging, corrugated materials, and related components
- Familiarity with distribution testing standards, including ASTM D4169, ASTM, ISO, TAPPI, USP, and EP
- Strong project management, technical problem-solving, interpersonal, and written and verbal communication skills
- Ability to work effectively in a cross-functional team environment and adapt to changing business priorities
- Experience writing test protocols, conducting technical evaluations, and performing packaging or material testing to support technical reports and material or component qualification
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The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
