Senior Project Engineer

Spectraforce Technologies; Waco (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

Spectraforce Technologies in Waco, TX is seeking a Global Engineering Project Engineer to lead capital projects for ophthalmic drug manufacturing equipment, utilities, and cleanroom renovations. The role focuses on project management from concept through commissioning in compliance with FDA and regional requirements.

You will coordinate cross-functional teams, develop integrated schedules, manage budgets and change control, and supervise external vendors and contractors on site at the Waco

Qualifications

• Degree or diploma in a Science, Engineering, Production or Construction Management discipline.
• Experience: minimum 5 years in pharmaceutical industry and 10+ years in construction management.
• Technical understanding of design drawings including HVAC, Clean Utilities, black utilities, electrical and process equipment.
• Ability to work with Architectural firms, CM teams and main trades to maintain schedules.
• Experience with projects >$10 Million.
• Familiarity with GMP pharmaceutical manufacturing technology and regulatory requirements.
• Experience with commissioning and validation of equipment and facilities.
• Strong presentation and reporting skills.
• Knowledge of construction safety requirements and safety metrics.
• Experience with capital funding requests and contractor turnover packages.

Responsibilities

• Leadership for new equipment or facility capital investment projects at the Waco site, including funding definition, preliminary engineering, detailed design, procurement support, schedule management, contractor management and commissioning.
• Lead stakeholders and SMEs through design reviews for facility and manufacturing equipment.
• Deliver capital plan latest best estimates as per finance schedule.
• Provide periodic project status reports and gate reviews to stakeholders; track progress.
• Control change during project execution.
• Coordinate and lead shut down related activities with all stakeholders.
• Lead final walkdowns of punch lists and turnover packages.
• Familiarity with global engineering standards for facilities, utilities and equipment.

Skills

Leadership

Project management

Scheduling

Stakeholder management

Communication

GMP knowledge

HAZOP

Cost tracking

Vendor procurement

Aseptic manufacturing

Education

Engineering degree

Job description

Position Title: Senior Project Engineer

Duration: 2 Years

Location/Site: Waco, Texas

We are now recruiting a Global Engineering Project Engineer to join our diverse Global Engineering Department in Waco, Texas Facility. Responsible for activities in support of capital projects within the client's network involving the ophthalmic drug product manufacturing equipment, utilities, and facility renovations and construction including but not limited to GMP manufacturing space, labs, and offices. associated with aseptic manufacturing.

The successful candidate will work with cross functional teams to develop integrated schedules and resourcing estimates for individual projects. The role will also involve supporting concept design, detailed design development and planning but the primary objective will be the project management of the design, building and commissioning of new cleanrooms, Utilities and Filling Line Equipment in line with regulatory requirements as defined by FDA and regional Ministries of Health as relevant.

A snapshot of your key responsibilities as a Global Engineering Project Engineer would be:

• Leadership for new equipment or facility capital investment projects at the client Waco, Texas site . Includes capital funding definition, preliminary engineering, detailed design, procurement support, schedule development / timeline management, contractor management and commissioning.
• Direct and lead stakeholders and SMEs through design reviews for facility and manufacturing equipment.
• Deliver capital plan latest best estimates (LBE) as per the established frequency by finance and project accounting.
• Deliver periodic project status reports and gate reviews to project stakeholders and track weekly and monthly project progress in line with agreed schedules.
• Control change during project execution.
• Coordinate and lead shut down related activities with all stakeholders.
• Lead final walkdowns of punch lists and engineering Turnover packages.
• Become proficient with global engineering standards with particular focus on engineering standards specific to facilities, Utilities and Equipment.

Education & Experience

• Degree or diploma in a Science, Engineering, Production or Construction Management discipline.
• Minimum 5 years' experience in pharmaceutical industry and 10+ years in construction management.
• Technical understanding of design drawings including HVAC, Clean Utilities, black utilities, electrical and process equipment.
• Demonstrated ability to work and communicate effectively with Architectural firms, CM teams and main trades in a fast-paced project environment. Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays.
• Previous experience of working in projects of a value greater than $10 Million.
• Ability to control and track change on the project.Knowledge of GMP pharmaceutical manufacturing technology and regulatory requirements and familiarity with aseptic manufacturing.
• Good presentation and reporting skills.
• Clear understanding of current legislative, industry and corporate expectations of process and construction safety requirements, with experience in participating in HAZOPs, and in tracking of construction safety metrics.
• Demonstrated ability to complete detailed cost and cash flow tracking for project capital and expense spending against project budgets.
• Demonstrated ability to develop detailed project schedules and track schedule progress during project execution.
• Experience of developing capital funding requests.
• Experience of procurement for equipment vendors and contractors and associated contracts reviews and issues of purchase orders.
• Understanding and experience of supporting process and building equipment commissioning and of pharmaceutical qualification and validation requirements for equipment and facilities.
• Experience of completing final walkdowns, close out of punch lists and handover of contractor turnover packages with vendors and contractors.
• Interpersonal skills to negotiate and reconcile differences.