Project Engineer

Job Title: Project Engineer

Department: Facilities

Reporting To: Associate Director, Engineering & Facilities

Classification: Full Time, Exempt

Salary Range: 75k-85k

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in Irvine, CA. Our 10 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Job Overview/Summary

• The Project Engineer is responsible for supporting ongoing cGMP manufacturing processes, developing/designing manufacturing processes for new products and equipment, and ensuring effective communication and coordination between all participating departments. The Project Engineer plans and conducts small to large scale projects requiring conventional types of plans, investigations, and equipment. Assignments include system, equipment or process design and development; equipment start-up, construction site responsibilities; preparation of specs or bid packages; regulatory and safety compliance. The Project Engineer's primary objective is to ensure that manufacturing processes are capable, compliant, in control, and continuously improved.

Essential Functions and Responsibilities

• Interfaces with technical operations, manufacturing, purchasing, and quality departments to design efficient and reliable manufacturing processes.
• Generates change controls to introduce new or modify existing equipment/systems.
• Develops and executes equipment and system qualification protocols to ensure compliance and adherence to cGMP and Company standards.
• Executes engineering studies related to in-process testing.
• Creates and improves Preventive Maintenance and Engineering-related procedures.
• Works closely with equipment manufacturers and suppliers to ensure equipment, systems, and components meet Company needs.
• Attends FATs (Factory Acceptance Tests) and authors/conducts SATs (Site Acceptance Tests) to verify equipment operates in accordance with cGMP and Company standards.
• Authors Engineering-related documents including User / Design / Functional / Configuration specifications for manufacturing equipment.
• Leads or participate in cross functional initiatives including safety and process improvements.
• Provides technical support and analysis for the resolution of process and equipment deviations and investigations.
• Develops and implements Corrective and Preventive Actions (CAPAs) including resulting Effectiveness Checks.
• Performs a periodic review of GMP systems to assess for potential trends and remedial actions that increase reliability of the operation.
• Assists in maintaining compliance of GMP manufacturing control systems to 21 CFR Part 11 and EU Annex 11 regulations.
• Organizes equipment and system training sessions for mechanics and operators.
• This job description is subject to change at any time.

Requirements

Education & Experience

• Bachelor of Science degree in Chemical, Mechanical, or Electrical Engineering or related studies required with 1-5 years' applicable experience.
• Previous experience in cGMP manufacturing environment.

Knowledge

• Background in Pharmaceutical, Medical Device, or Biotechnology industry is highly desired.

• Strong knowledge in the manufacturing of Solid Oral Dosage products and processes is a plus.
• Working knowledge of Programmable Logic Controllers (PLCs) and other industrial automated or control systems is desired.
• Knowledge of 2D and 3D design software (e.g. AutoCAD, SolidWorks).
• Knowledge of FDA regulations is highly desired.
• General understanding of Lean Manufacturing and Six Sigma principles.

Physical Requirements

• Occasionally required to climb or balance.
• Occasionally required to lift and/or move up to 50 pounds.
• Occasionally exposed to outside weather conditions and risk of electrical shock.
• May be exposed to high noise environments.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Preferred Qualifications

• Able to work independently with minimal direction and supervision.
• Must have strong technical writing skills.
• Proficient with Microsoft software (e.g. Word, Excel, Project, PowerPoint, Outlook).
• Able to work effectively with a Computerized Maintenance Management System (CMMS) and Building Management System (BMS) and instruct others on the operation.
• Able to establish and maintain cooperative working relationship with individuals contacted in the course of work.
• Able to understand and follow oral and written instructions.
• Able to communicate clearly and concisely, both oral and writing.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Benefits

We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides employees with a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.

EOE and Accommodation

We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing [email protected]. If you are selected to interview for a position, you may also request an accommodation with our team directly.

Notice to Agency and Search Firm Representatives

BioDuro-Sundia is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro-Sundia employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro-Sundia. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.