Process Engineer III

Job DescriptionJob Description

Intermediate engineering position that completes all deliverables and supports production of a process under general direction. 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. Implements higher level of solutions and guidance based on experience. Works under only general direction. This position is not remote.

DUTIES and RESPONSIBILITIES:

• Follows listed PPE requirements and chemical handling requirements, addresses safety issues promptly, and communicates safety issues to fellow employees.

• Technical lead in PHA and PSSR reviews. Develop safe solutions to encountered safety problems.

• Uses engineering skills to design 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.

• 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.

• Leads in the of GMP documentation and operator training, including comments and variances. Provide technical knowledge to variance and CAPA investigations.

• Prepares new batch records and work instructions.

• Troubleshoots processes to reduce downtime, improve cycle time, and increase productivity.

• Provides team leadership to projects.

• Activates and qualifies facilities and equipment.

• 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.

• Works with senior staff oversight to resolve problems encountered in the manufacturing environment.

EDUCATION AND EXPERIENCE

Typically requires 4-9 years of related experience and a bachelor'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 .

Experience with low OEL engineering techniques and high containment equipment

COMPETENCIES/SKILLS

• Strong interpersonal and verbal communication skills

• Must have a high consciousness for personal safety

• Strong attention to detail

• Team oriented

• Highly motivated and willingness to learn

CERTIFICATIONS and LICENSES

• Potent Compound training

This job description does not constitute a contract of employment or otherwise limit employment-at-will rights at any time.