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Biomedical / Chemical Engineer

Company Name:
Human Capital Resource LLC
Engineering Project Manager - Rensselaer, NY
Manages the design, specification, and installation of new and renovated biopharmaceutical process equipment. Provides engineering support and problem solving for existing equipment and manufacturing processes.
Essential Duties and Responsibilities include, but are not limited to, the following:
- Manages the scope, deliverables, schedule, budget and quality of engineering projects related to cGMP process equipment, piping, and controls.
- Responsible for the identification and mitigation of risks to ensure business continuity and protect the company from loss.
- Responsible for preparation and presentation of project status reports.
- Manages the design review, site acceptance, and installation of equipment.
- Prepares Piping & Instrumentation Diagrams and other related drawings and documents.
- Supports QA/Validation Department through preparation of design documents and protocol review.
- Recommends and manages implementation of appropriate corrective/preventative actions for existing equipment and manufacturing processes.
- Evaluates, approves, prepares, and executes change control documentation.
- Acts as Subject Matter Expert during regulatory inspections and internal investigations.
- Supports Manufacturing and Maintenance activities as technical advisor.
- Maintains clean and safe working environment by enforcing procedures, policies, and regulations.
- Maintains company reputation by enforcing compliance with local, state, and federal regulations.
Supervise:
- Contract Engineers (Design, Process, Project, Electrical)
- Construction Contractors (Electrical, Mechanical)
- Automation Contractors
Experience And Required Skills :
Knowledge and Skills:
- Thorough knowledge of cGMPs and sanitary equipment design requirements.
- Working knowledge of process control systems and automation.
- Advanced knowledge of engineering documentation required for cGMP process equipment.
- Substantial knowledge of clean room design & function and biopharmaceutical equipment.
- Strong written and oral communication skills.
- Solid supervision, leadership, and project management skills.
- Ability to understand and manage project plans, budgets, and schedules.
- Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
Education and Experience:
- Requires BS/BA or higher in chemical or biochemical engineering.
- Requires 7+ years of experience in equipment process or facilities engineering.
- Requires experience with biopharmaceutical process equipment.
- Formal training in project management preferred.
This full time position is in a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. My client markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.

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