You would be a great candidate for this position if you have the following:
Bachelors degree in Chemical Engineering or equivalent. (Environmental or safety background will not give them an advantage over other engineering disciplines.)
At least 2 years' relevant experience in a cGMP manufacturing environment.
Have worked on projects independently.
Intermediate level engineering position that completes all deliverables and supports production of a process under some supervision. This includes but is not limited to mass balances, scale up, instruction writing, emission calculations, process startup, training equipment setup, equipment cleanings, process oversight, equipment and process troubleshooting. Works under general supervision.
Duties and Responsibilities:
Assists in the completion of Process Safety information and participates in Process Hazard Analysis.
Uses engineering skills to design small projects for enhanced safety, quality and or productivity improvements.
Follows cGMP guidelines for operation comments and batch records, other change control requirements, and related documentation practices.
Takes the lead in generation of GMP documentation and operator training, including comments and variances. Provides technical knowledge to variance and CAPA investigations.
Writes and implements change controls under senior advisement.
Monitors existing processes, ensuring that batch records are maintained, variances are investigated, and day to day activities are properly planned.
Conducts product changeovers, preparation of cleaning instruction, and leading in set up operations.
Provides team leadership to small projects.
Activates and qualifies facilities and equipment.
Prepares new batch records and work instructions.
Develops and presents process training for production personnel.
Works with senior staff oversight to resolve problems encountered in the manufacturing environment. Troubleshoots processes to reduce downtime, improve cycle time, and increase productivity.
Modifies piping and instrumentation drawings, flow sheets, and emission calculations.
Independently evaluates, selects, and applies engineering techniques, procedures and criteria using judgement in making adaptations and modifications. Follows listed PPE requirements and chemical handling requirements, addresses safety issues promptly, and communicates safety issues to fellow employees.
Helps develop safe solutions to encountered safety problems.
EDUCATION AND EXPERIENCE
Typically requires 2-5 years of related experience and a bachelor's degree or 0-2 years of related experience and a master's degree or equivalent experience.
Bachelor's degree in Chemical Engineering or equivalent required
At least one (1) year of relevant experience in a cGMP environment preferred.
COMPETENCIES/SKILLS
Strong interpersonal and verbal communication skills
Must have a high consciousness for personal and laboratory safety
Strong attention to detail
Team oriented
Highly motivated and willingness to learn.
CERTIFICATIONS and LICENSES
Not Applicable
This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time
