POSITION OVERVIEW:

We are seeking a Sr. Project Engineer with 2-5 years of experience supporting engineering, commissioning, validation, and operational readiness activities within GMP-regulated life sciences environments. The ideal candidate will have hands-on experience supporting capital projects, facility and utility systems, engineering documentation, and cross-functional project execution. Prior validation experience supporting capital projects is preferred. This role is suited for an engineer who has developed a solid technical foundation and is ready to take on increased responsibility in coordinating and executing engineering, validation, and commissioning activities throughout the project lifecycle.

WORK LOCATION:

Travel to client sites may be required up to 100%, depending on project needs and client expectations.

KEY RESPONSIBILITIES:

(This list is not exhaustive and may be supplemented or adjusted as needed.)

• Support the execution of capital projects from design through commissioning, qualification, validation, and startup activities.
• Perform startup and commissioning of building and utility systems such as HVAC, chilled water, water systems, electrical systems, fire protection, pH neutralization, and waste systems.
• Support validation and qualification activities, including protocol development, execution, discrepancy resolution, and final reporting.
• Generate and manage engineering and validation lifecycle documentation, including impact assessments, URS/FRS documents, FAT/SAT documentation, commissioning protocols, qualification protocols, ETOPs, and P&IDs.
• Conduct drawing walkdowns and verify field installation of equipment, facilities, and utility systems.
• Develop and execute commissioning and qualification protocols and reports.
• Support troubleshooting, issue resolution, and risk assessments during commissioning, qualification, and startup activities.
• Utilize systems such as BMS, PCS, and CMMS; experience with KNEAT is a plus.
• Coordinate with cross-functional teams including engineering, facilities, validation, operations, quality, and project management to support project deliverables.
• Assist in planning and scheduling project tasks, tracking progress, and ensuring timely completion of milestones.
• Communicate effectively with stakeholders to provide updates, escalate issues, and maintain alignment across project teams.
• Ensure all work complies with GMP, safety, quality, and regulatory requirements.

QUALIFICATIONS AND REQUIREMENTS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education

• Bachelor's Degree in Engineering or a related technical field.

Technical Experience

• 2-5 years of experience in engineering, commissioning, validation, facilities, or operations within a GMP-regulated pharmaceutical, biotechnology, or industrial environment.
• Experience supporting capital projects within GMP-regulated manufacturing or facility environments.
• Prior validation experience supporting capital projects is preferred.
• Hands-on experience with startup, commissioning, qualification, or validation of facility, utility, equipment, or process systems.
• Experience generating and managing engineering and validation documentation.
• Experience with drawing walkdowns, field verification, and construction turnover activities.
• Familiarity with cGMP documentation practices and validation lifecycle methodologies.
• Familiarity with BMS, PCS, CMMS, or similar technical systems.
• Experience with KNEAT or digital validation documentation platforms is a plus.

Knowledge, Skills, and Abilities

• Strong understanding of facility, utility, equipment, and process systems within regulated manufacturing environments.
• Working knowledge of commissioning, qualification, validation, and capital project execution methodologies.
• Excellent documentation, organizational, and technical writing skills.
• Ability to manage multiple tasks, priorities, and deadlines in a fast-paced project environment.
• Strong communication and interpersonal skills.
• Detail-oriented with strong analytical and problem-solving abilities.
• Ability to work independently and collaboratively across multidisciplinary teams.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS PROGRAM:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous paid time away program and company-paid holidays.

Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.