Senior Engineer - Manufacturing / Commissioning & Qualification (C&Q)

BioPharma Consulting JAD Group

About The Position

The Senior Engineer is responsible for providing technical leadership in support of manufacturing operations, process optimization, commissioning and qualification (C&Q), validation, and capital projects within a regulated manufacturing environment. This role independently leads engineering initiatives, develops technical solutions to complex operational challenges, and ensures manufacturing systems, equipment, and processes meet quality, regulatory, and business requirements. The ideal candidate has experience in packaging processes, equipment qualification, validation, and cross-functional project execution within biotechnology, pharmaceutical, or other highly regulated manufacturing environments.

Requirements

Strong understanding of engineering principles and manufacturing processes.
Knowledge of GMP, GLP, and validation requirements within regulated industries.
Experience with process optimization and technical troubleshooting.
Excellent analytical, problem-solving, and decision-making skills.
Strong technical writing and documentation abilities.
Effective communication and presentation skills.
Project planning, scheduling, and budget management experience.
Ability to manage multiple priorities and cross-functional projects simultaneously.
Leadership, mentoring, negotiation, and stakeholder management skills.
Ability to coordinate contractors, vendors, and engineering service providers.
Doctorate, OR Master's degree with 2+ years of Engineering experience, OR Bachelor's degree in Engineering with 4+ years of Engineering experience.

Nice To Haves

Experience supporting biotechnology, pharmaceutical, medical device, or other regulated manufacturing environments.
Experience with packaging equipment and packaging process engineering.
Experience leading Commissioning & Qualification (C&Q) activities.
Strong knowledge of equipment validation and lifecycle management.
Experience authoring and executing IQ, OQ, PQ, and characterization protocols.
Experience supporting capital projects and equipment installation.
Knowledge of risk assessment methodologies and validation lifecycle practices.
Familiarity with electronic quality and document management systems.

Responsibilities

Lead process optimization, troubleshooting, and continuous improvement initiatives for manufacturing operations.
Develop and implement engineering solutions for complex technical and operational challenges.
Design, evaluate, and implement system modifications, equipment upgrades, and process improvements.
Apply engineering principles to support manufacturing, process development, facilities, utilities, and capital projects.
Develop engineering procedures, technical standards, and best practices.
Provide technical leadership and mentorship to engineers, technicians, and project team members.
Develop and execute Commissioning & Qualification strategies aligned with project and regulatory requirements.
Define system boundaries and determine direct and indirect impact systems.
Lead risk assessments using industry methodologies to establish qualification scope.
Develop C&Q plans, schedules, and resource forecasts.
Coordinate Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, startup, and field verification activities.
Review and approve commissioning documentation and testing results.
Author, review, approve, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
Develop characterization protocols and oversee characterization studies.
Prepare qualification reports, validation summary reports, and supporting documentation.
Ensure traceability from User Requirements Specifications (URS) through qualification testing.
Support equipment installation, startup, and validation activities.
Ensure engineering, validation, and qualification documentation complies with GMP regulations and industry standards.
Maintain documentation within electronic document management systems.
Support data integrity principles throughout engineering and validation activities.
Participate in internal audits and regulatory inspections.
Lead engineering risk assessments related to manufacturing systems and equipment.
Evaluate and manage Change Control activities affecting validated systems.
Investigate deviations and implement corrective and preventive actions (CAPA).
Assess the impact of equipment or process changes on validated systems.
Lead engineering projects from planning through implementation while managing scope, schedule, budget, and quality objectives.
Coordinate activities with contractors, consultants, equipment vendors, and cross-functional teams.
Develop project budgets, schedules, and technical documentation.
Provide project status updates and communicate risks to stakeholders.
Partner with Manufacturing, Engineering, Validation, Quality, Process Development, Facilities, Supply Chain, and Project Management teams.
Provide technical expertise during new equipment installations, process improvements, and capital projects.
Support technology transfer and new product introduction initiatives.
Mentor junior engineers and provide technical guidance across project teams.