- Maintains the compliance of cGMP utility operations through initiating, executing and closing change records through the management of change process.
- Participates in developing courses of action that may impact multiple functions in the organization.
- Reviews work results with manager upon completion. Recommends to manager work priorities, timelines and resources
- Reviews and provide recommendations on operational standard operating procedures. design drawings, which may include PFDs that incorporate mass balances and P&IDs, which include all line sizing, instrumentation and control philosophies.
- Interacts with vendors concerning contracts of significant financial value and select vendors based on the most appropriate combination of price, quality and delivery. Reviews and approves vendor information packages, including drawings and specifications. Makes recommendations to senior staff.
- Assists in the start-up and troubleshooting of individual pieces of equipment and critical clean utility systems.
- Assists by providing information to develop utility projects budget, schedules, resource planning, problem solving, etc, in alignment with corporate objectives.
- Generates controlled documents to support the start-up, operation, validation and maintenance of equipment and systems.
- Reviews drawings and documents produced by external groups for utility systems.
- Performs factory inspections of vendor-supplied equipment to ensure that construction and performance meets specifications.
- Provides input into the validation of equipment and associated utilities through protocol review. Assist operations technical validation staff in the execution of validation protocols.
- Proposes ideas for new projects in alignment with strategic planning.
- Provides technical support to manufacturing.
- Provides technical assessments for investigations, discrepancies, validation and change control.
- Manages corrective actions as a result of investigations.
- Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.
- Performs equipment and system studies, research/evaluate equipment components, review and modify equipment operation as a result of troubleshooting.
- Presents data and concepts at department, project team and other meetings within company.
- May provide direction to sub-contracting groups in the design and installation of process and clean utility systems. Oversee design specification testing and perform field inspection services.
- May perform process design services for facility projects, upgrades and capacity expansions, equipment upgrading and replacement.
- May act as a team leader to coordinate activities within the department for equipment troubleshooting and repair.
- Other responsibilities as assigned by management.
Education and Experience
- Bachelor’s degree in Engineering and 5-7 years applicable equipment, clean utility and process system experience, or Master’s degree in Engineering (Chemical preferred) and 3-5 years applicable equipment, clean utility and process system experience.
- Minimum of 3 year applicable instrument and control system experience.
- Minimum of 1 year in the pharmaceutical/biotech industry/GMP experience.
Knowledge, Skills and Abilities
- Experience in central utilities, manufacturing, design or construction.
- Understanding of clean room or classified area design/requirements.
- Good working knowledge of Microsoft based programs and systems.
- Working knowledge of Windows applications for accessing control system software packages used throughout the utility and building.
- Knowledge of central utility equipment and supporting utility systems, especially those related to sanitary and sterile operations.
- Knowledge of biopharmaceutical process operation and process control.
- Knowledge of process, clean utility and mechanical systems (pumps, valves, materials) as foundation for troubleshooting, design and equipment evaluation.
- Knowledge of process controls to enhance troubleshooting abilities and for application to future designs.
- Validation experience related to equipment, clean utility and process systems, including requirements for documentation and testing.
- Knowledge of cGMP guidelines, experience in generation of controlled documents and some experience in equipment start-up and validation.
- Ability to generate engineering drawings and specifications.
- Good organization and time utilization skills.
- Strong communication skills, both written and verbal.
- Proven ability to use creativity and innovation to address urgent and/or complex problems and propose solutions.
- Requires use of a variety of technical skills to solve multiple disciplinary engineering challenges.
- Ability to work autonomously on assignments and projects.
- Comply with GMP requirements (gowning, documentation, procedures) for performing work within the manufacturing plant.
Work Environment/Physical Demands/Safety Considerations
- Work in standard office environment.
- May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.
- May work with hazardous materials and chemicals.
Job ID: 201804-101747