Schedule:
Administrative Shift, with availability to support non-standard shifts based on business needs
Position Summary:
Our client is seeking an Engineer to support process optimization, troubleshooting, manufacturing operations, and engineering projects within a highly regulated pharmaceutical/biotechnology environment.
The ideal candidate will have an engineering background, strong analytical and problem-solving skills, and the ability to apply engineering principles to operational challenges, system modifications, validation activities, and projects of limited to moderate scope and complexity.
Key Responsibilities:
Support process optimization and troubleshooting activities within operations, manufacturing, pilot plant, or capital project environments.
Apply engineering principles to support system modifications, experiments, and capital projects.
Analyze operational and engineering data and present clear interpretations and recommendations.
Provide solutions to technical problems of moderate scope and complexity.
Evaluate and apply standard engineering techniques and procedures under general supervision.
Complete routine technical assignments and investigations involving a limited number of variables.
Serve as a technical resource for equipment and systems troubleshooting.
Support daily operations when needed to meet schedules or resolve complex technical issues.
Assess the operational performance and regulatory compliance of equipment and systems.
Collaborate with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams.
Support the development of requirements and recommendations for system modifications.
Assist project managers with design, engineering, and construction projects while maintaining schedule and budget requirements.
Collaborate with consultants, architects, and engineering firms on standard design documentation.
Review and evaluate quotes for equipment modifications or installations.
Prepare basic project cost estimates and schedules.
Perform additional functions as assigned based on business needs.
Preferred Qualifications:
Chemical Engineering background preferred.
Experience with Statistical Analysis.
Biotechnology industry experience is a plus.
Experience with Drug Substance Manufacturing or technical support is a plus.
Working knowledge of pharmaceutical/biotechnology processes.
Familiarity with validation processes and validation protocol execution.
Familiarity with documentation requirements in a highly regulated environment.
Ability to interpret and apply GLP and GMP requirements.
Ability to apply engineering principles to manufacturing operations.
Experience developing solutions to routine technical problems.
Ability to operate specialized laboratory equipment and computer systems as required.
Strong problem-solving and applied engineering skills.
Basic technical report writing and presentation skills.
Strong personal organization and ability to manage change.
Familiarity with validation protocol writing.
Strong analytical problem-solving skills and computer literacy.
Technical knowledge related to equipment and systems.
Education & Experience:
Bachelor’s degree in Engineering with 2 years of engineering experience.
Interested candidates: Please submit your updated resume through ProQuality Network or contact our recruiting team for consideration.
