Process Engineer - Exelead
EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis. Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking candidates for a Process Engineer.
This is a professional mid-level technical position that will be responsible for analytical testing of finished product, raw materials, stability and special test requests. Position also requires analytical testing in support of protocols related to method transfers, method validations, laboratory investigations, and instrument qualifications.
Major Position Activities & Responsibilities:
- Responsible for adhering to the Environmental, Health and Safety program.
- Perform routine chemistry testing on raw materials, in-process samples, finished product samples,
and stability samples according to validated methods.
- Perform common laboratory procedures such as pH, weighing on analytical balances, glassware
preparation, equipment calibrations, and peer review of test parameters and reagent preparations.
- Execute protocols for method transfers, method validations, stability studies, and cleaning validations
- Represent the chemistry laboratory department as technical expert on special studies and validations
- Support manufacturing process control & process improvement projects
- Management of periodic reviews of analytical test procedures and SOPs as required.
- Performs routine lab maintenance, special projects, and other duties as assigned.
- Assist in the training of entry-level analysts.
- 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.
- 5% Executing protocols for method qualifications, method validations, and qualification of new
- 5% Revising SOPs and ACMs for the chemistry lab as directed.
- 5% Laboratory Maintenance duties
- 5% Training of entry-level analysts
- 80% Individual contributor as bench analyst
- BS in chemistry or related discipline with a minimum of two or more years of experience in the
pharmaceutical industry (including in pharmaceutical lab setting).
- Demonstrated ability to perform analytical testing using the majority of the analytical equipment used
in the analytical laboratory including HPLC, GC, TLC, UV/VIS Spectroscopy, FTIR Spectroscopy,
Particle Size, Electrophoresis. Working knowledge of Empower 3 desired.
- Must have solid cGMP expertise in testing/manufacturing environments.
- Technical knowledge of bio-analytical and chemistry analytical techniques.
- Familiarity with analytical validations, method transfers, cleaning validations, and scientific research.