Lead Engineer, Quality Engineering, Regulatory Compliance Specialist

Lead Engineer, Equipment Commissioning and Qualification (ECQ) Delivery

The Lead Engineer, Equipment Commissioning and Qualification (ECQ) Delivery, plays a key role in supporting the successful implementation of equipment, utilities, facility, and laboratory instrument projects at multi-use sites. This position involves close collaboration with internal stakeholders and external service providers to ensure timely and compliant execution.

The individual in this role is responsible for managing commissioning and qualification projects for new equipment, utilities, and facilities, as well as maintaining existing systems in a qualified and validated state in accordance with established policies and procedures.

With minimal supervision and general guidance, the Lead Project Engineer performs routine tasks and applies foundational project management and analytical skills to identify and resolve problems of limited scope.

As a developing team leader, this person works closely with their supervisor and team to meet project goals while building strong relationships with other departments. They will also be responsible for managing contract project teams to ensure work is completed on time and in compliance with requirements.

Duties/Responsibilities

Commissioning and Qualification

Activities:

• Maintain qualified equipment systems in compliance with policies, guidelines and procedures
• Develop qualification protocols, and associated reports while adhering to a change management process
• Execute equipment qualifications and validation protocols
• Supervise vendors for qualification functions
• Support development of equipment operational procedures
• Support equipment validation activities
• Develop validation/qualification deliverables such as Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports
• Support Change Management process

Project Work Support:

• Manage equipment implementation projects including scheduling, site prep, installation, qualification, and turn over to business area
• Support internal customer groups in the operation, calibration, and preventive maintenance of equipment to meet business needs in accordance with required schedules or dates
• Lead and oversee contract project teams to ensure timely execution and adherence to all compliance and quality requirements
• Complete all qualification and validation documentation with accuracy, completeness and compliance to BMS standards

Customer Service and Support:

• Regularly review, prioritize and promptly respond to customer equipment qualification and support requests
• Provide technical support and guidance on equipment qualification issues. Interfaces with customers to ensure all expectations are being met
• Provide technical support and guidance on equipment, utilities, facilities, and computerized systems qualification and validations issues
• Maintain a positive relationship with all team members and site customers while promoting a positive team environment

Regulatory Responsibilities:

• Ensure equipment, facilities and programs are maintained in compliance
• May participate in deviation investigations as SME

Reporting Relationship:
Manager, Senior Manager or Associate Director

Qualifications

Specific Knowledge, Skills, Abilities:

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21
  
  CFR part 11, computer systems validation requirements and good documentation practices
• Knowledge of pharmaceutical, manufacturing and laboratory systems
• Understanding of investigations, deviations and CAPA management in a regulated pharmaceutical industry
• Strong written and verbal communication skills
• Excellent interpersonal skills with experience dealing with a diverse workforce
• Strong multi-tasking ability in conjunction with proven organizational skills
• Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks/assignments with others that may impact timely completion
• Ability to effectively manage multiple tasks and activities simultaneously
• Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business tools

Education and Experience:

• BS in Engineering or Science related discipline preferred but can be substituted with sufficient relevant experience
• Minimum of 4 years of experience performing/supporting activities in a GMP environment
• Minimum of 3 years of experience in equipment, facility or utility qualification
• Minimum of 2 years of project management experience in a GMP environment