- Bachelor's Degree
- Master's Degree
- Word Processing
- FDA Regulations
- Construction Estimating
- Alternative Dispute Resolution
This position will provide key engineering and validation support and project coordination primarily to the manufacturing process side of plant operations. Additionally, technical support for process and product investigations will be offered.
Major Position Activities & Responsibilities
Provide technical support for the manufacturing processes, including process investigations, process changes, and technical transfer and scale up of new product introductions.
Coordinate and execute tech transfer projects in support of new clinical and commercial Exelead products and contract manufacturing opportunities. In addition to project management responsibilities described above, individual will be required to interface with external clients and contractors in support of contract manufacturing opportunities.
Coordinate and execute small to medium scale and/or complex technical projects up to $250K in value. Associated functions include process and equipment design engineering, project estimating and budgeting, developing capital appropriation requests, documentation updates, scheduling and overall project coordination and oversight. Project staffing will be comprised of personnel from various departments on-site, as well as contract personnel. Individual will be required to coordinate multiple projects of varying scope and size concurrently.
Provide project and process engineering support for technical projects. Associated tasks include equipment specification and procurement, process development, drawing development, protocol development and execution.
Interpret, modify and create engineering drawings, including Piping and Instrumentation Diagrams, Piping Drawings, Layouts, Isometrics, Building Mechanical, Instrumentation and Electrical Drawings.
Create Standard Operating Procedures (SOPs) for new equipment/processes, and update existing SOPs.
Perform process and utility calculations as related to hydraulic design, heat transfer, material balances, etc.
Develop new and modify existing control loops/strategies. Create and interpret PLC control ladder logic
Research, write, coordinate, and execute validation protocols including IQ, OQ, PQ for process, equipment, facility, utility, computer, and cleaning validation. Execute validation test functions in support of approved protocols. Review, summarize and present data in a Summary Report for management review and approval. Perform revalidations.
Perform special projects and other duties as assigned.
As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
B.S. in Chemical or Biochemical Engineering. M.S. a plus.
One or more year’s minimum experience in pharmaceutical operations as validation engineer, process engineer, project engineer or similar capacity.
Previous experience in the qualification of various types of sterile facility equipment, such as:
Sterilization Technology (Steam, Dry Heat, VHP, etc)
Temperature Mapping (Various chambers)
Aseptic Equipment (Washers, Tunnels, Cappers, RABS, Isolators etc)
Pharmaceutical Grade Utilities
In-depth knowledge of US and European GMP requirements, FDA guidelines, and industry validation expectations is required.
In-depth knowledge of aseptic bulk process formulation, aseptic filling, process and packaging equipment, unit operations, process control systems, computer systems, equipment cleaning, sterility assurance, process hazards and safety.
Strong hands-on skills are desirable.
Advanced PC skills with spreadsheets, word processing and databases.
Employee must be self-motivated, highly organized, and conscientious. Effective interpersonal skills are required to interface with internal and external clients as well as outside contractors. Must be able to work and make decisions independently as well as with a team. Must be able to work in technically and mentally demanding situations. Strong verbal and written communications skills are required. Must be well organized to effectively coordinate multiple projects concurrently. Strong mediation skills are essential in gaining and maintaining cross-departmental project support.
While performing the duties of this job, the employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and peripheral vision.
Employee must have sufficient mobility to work in a process environment. The employee will be required to climb stairs and ladders to perform the functions of this job.
Employee must be available to work various shifts as required to maintain production schedule.