Technical Operations Specialist III (Onsite)

Role Summary

Technical Operations Specialist III (Onsite) supports the Technical Operations department by evaluating, selecting, applying, and adapting engineering techniques and criteria in manufacturing processes. The role optimizes manufacturing processes for new and existing products, including ingredient addition, blending, sterilization, and transfer methods, and resolves process and equipment issues. It involves preparing drawings, specifications, calculations, charts, and graphs, and ensuring compliance with codes, cGMP, and safety standards to support production operations.

Responsibilities

• Provide on-going support to production operations and maintenance to improve the reliability and efficiency of all compounding operations, based on knowledge and experience with manufacturing processes.
• Prepare and/or modify documents including conceptual designs and process development reports; Block Flow Diagrams (BFD) and Process Flow Diagrams (PFD); Process and Instrumentation Diagrams (P&ID); process engineering calculations; basis of design process scope documents; equipment layouts; equipment specifications, data sheets, and bid tabulations; User Requirement Specifications (URS); and project status reports.
• Apply engineering and process knowledge to provide technical support to Operations and maintenance staff responsible for equipment in production areas.
• Support the introduction of new products and processes and drive continuous-improvement efforts for existing products.
• Coordinate with other engineering and operational disciplines (mechanical, civil/structural, electrical, instrumentation, automation, architecture, etc.) to ensure coordinated design and complete deliverables on projects.
• Interface with internal customers and vendors to define project scope, resolve technical issues and assist with preparation of required procurement documents.
• Size and select equipment, materials, and process systems, and review vendor drawings for design accuracy and compliance with specifications.
• Incumbent has full authority to make decisions and/or take action that is required to carry out job duties. Internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.
• Regulated Responsibilities (including cGMP and EHS): maintain compliance with criteria established by governmental agencies and regulatory bodies and ensure environmental, health, and safety requirements are met.

Qualifications

• Five years of process engineering experience, including process engineering experience (addition/mixing/transfer) with solutions, suspensions, or ointments.
• Two years of regulatory experience in the pharmaceutical industry (preferred).
• Thorough knowledge of pharmaceutical manufacturing processes such as mixing, sterilization, clean-in-place, steam-in-place, sanitary piping, tank design, and process automation.
• Knowledge of critical / non-critical utility design, installation, and engineering techniques in support of technologies such as sterile solutions, suspensions, emulsions, ointments, creams and gels.
• Quality System knowledge (FDA/cGMP, ISO 13485/13488).
• Ability to thrive in a team environment; strong problem-solving and risk analysis skills.
• AutoCAD knowledge is a plus.
• Excellent computer skills in Microsoft Suite.
• Ability to read, comprehend, write, and communicate effectively in English; ability to carry out detailed written or oral instructions.
• Detail-oriented and self-motivated.

Education

• BS in Engineering, Chemical, Electrical, Mechanical or related field of study (required).

Additional Requirements

• Physically able to continuously stand and walk.
• Physically able to lift up to 40 lbs.