Senior Project Engineer at Syner-G BioPharma Group in Oceanside, CA

POSITION OVERVIEW:

Syner-G is seeking a Senior Project Engineer to support capital projects at a large pharmaceutical manufacturing facility utilizing both single-use and stainless-steel processing systems.

The Senior Project Engineer will provide owner-side engineering and project execution support for facility, utility, infrastructure, and manufacturing-support projects. Typical projects may include HVAC, cleanrooms, process and plant utilities, cooling towers, electrical systems, laboratory and manufacturing-area modifications, equipment installations, and facility upgrades.

The role will coordinate engineering design, procurement, construction, commissioning, and turnover activities while serving as a key interface between site Engineering, Facilities, Manufacturing, Quality, contractors, vendors, and external design partners.

KEY RESPONSIBILITIES:

• Manage multiple facility and infrastructure capital projects from scope development through design, construction, startup, and turnover.

• Support projects involving HVAC, electrical systems, clean utilities, plant utilities, cooling towers, manufacturing infrastructure, laboratories, and facility modifications.

• Develop project scope, technical requirements, budgets, schedules, procurement plans, and execution strategies.

• Serve as the owner-side engineering interface with design firms, contractors, vendors, and internal stakeholders.

• Review and approve engineering drawings, specifications, shop drawings, submittals, RFIs, equipment packages, and other technical deliverables.

• Provide technical responses to requests for information and coordinate resolution of field and design issues.

• Contribute to technical design of facility equipment, utilities, and associated infrastructure.

• Coordinate process, mechanical, electrical, structural, architectural, HVAC, plumbing, automation, and construction interfaces.

• Confirm equipment layouts, utility requirements, facility interfaces, and installation requirements.

• Support equipment and system procurement, vendor evaluations, technical bid reviews, and contractor coordination.

• Participate in FAT, SAT, commissioning, qualification, startup, and turnover activities as applicable.

• Coordinate construction activities, shutdown work, tie-ins, equipment installations, and work within active GMP manufacturing areas.

• Develop and maintain project schedules, cost forecasts, action logs, risk registers, and project status reports.

• Monitor project costs, commitments, forecasts, change orders, and contractor performance.

• Support development and implementation of Facility Control Plans and other project-specific execution controls.

• Collaborate on project-related change controls, deviations, CAPAs, and GMP documentation.

• Support preventative maintenance, asset turnover, spare-parts planning, and integration with site maintenance systems.

• Identify technical, schedule, cost, safety, and operational risks and drive mitigation and resolution.

• Ensure projects consider constructability, maintainability, operability, safety, GMP requirements, and future facility needs.

• Support development and execution of commissioning and qualification strategies for new and modified facility, utility, and equipment systems.

• Coordinate FAT, SAT, commissioning, startup, IQ/OQ, and turnover activities with Engineering, Validation, Quality, Facilities, Operations, vendors, and contractors.

• Review and support development of commissioning plans, qualification protocols, test scripts, turnover packages, and associated technical documentation.

• Ensure design, installation, commissioning, and qualification activities remain aligned with URS, design requirements, GMP expectations, and project milestones.

• Track and resolve commissioning punch-list items, discrepancies, deviations, and qualification issues through closure.

• Support system handoff from construction and engineering into validated and operational use.

• Coordinate with Validation/CQV teams to ensure projects are designed and executed with qualification requirements considered early in the project lifecycle.

• Support change control, validation impact assessments, and documentation associated with equipment, utility, and facility modifications.

QUALIFICATIONS AND REQUIREMENTS:

Education:

• Bachelor’s degree in Chemical Engineering, or related technical discipline.

Technical Experience:

• 5-7+ years of project engineering, facilities engineering, capital-project, or construction experience.

• Experience supporting pharmaceutical, biotechnology, medical-device, or other regulated manufacturing environments.

• Demonstrated experience managing multidisciplinary facility or utility projects.

Knowledge, Skills, and Abilities:

• Ability to interpret engineering drawings, specifications, P&IDs, equipment layouts, electrical one-lines, and construction documents.

• Experience coordinating engineering firms, contractors, equipment vendors, and internal site stakeholders.

• Strong project controls experience including schedule, budget, procurement, forecasting, and risk management.

• Working knowledge of GMP project execution, change control, commissioning, qualification, and turnover.
• Strong communication, problem-solving, and stakeholder-management skills.

Preferred Experience

• Large-scale pharmaceutical or biologics manufacturing facilities

• Single-use and stainless-steel manufacturing environments

• HVAC and cleanroom systems

• Cooling towers, chilled water, steam, compressed air, and other plant utilities

• Purified water or clean utility systems

• Electrical infrastructure

• Facility shutdowns and tie-ins

• Construction management

• Commissioning / CQV / Validation Support

• Laboratory and manufacturing-area renovations

• Equipment installation and startup

• Project cost forecasting

• RFIs, submittals, shop drawings, and design reviews

• CMMS / asset-management systems

• Commissioning and qualification

• Owner’s-representative or site project-engineering experience

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 and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.

COMPENSATION:

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $120,000 yearly in our lowest geographic market up to $140,000 yearly in our highest geographic market. Pay is based on several factors including market location and may vary depending on job‑related knowledge, skills, and experience.

Applicants must have current work authorization when accepting a position at Syner‑G. Currently, Syner‑G is unable to sponsor or take over sponsorship of an employment Visa at this time.

LEGAL STATEMENT:

Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employer. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.