Job Description

ATTENTION MILITARY AFFILIATED JOB SEEKERS - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military Spouses, Wounded Warriors, and their Caregivers. If you have the required skill set, education requirements, and experience, please click the submit button and follow the next steps. Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Position Summary
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

Additional Qualifications/Responsibilities

Qualifications

Specific Knowledge, Skills, Abilities:

Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR 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
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Compensation Overview:

Summit West - NJ - US: $88,450 - $107,182
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.