Job Description

Job Description

Job Description

Description:

Advanced engineering position that leads in process design and execution. Provides mentorship to less senior staff on process design. Implements new solutions for process safety, quality, and performance. Consults with management to implement production solutions. Implements high level of solutions and guidance based on experience. Work is highly independent.

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

• Leads in the completion of Process Safety information and participates in Process Hazard Analysis. Conduct safety analysis to ensure that process is safe.

• Anticipates potential safety issues and proactively prevents safety events. Leads in the development of 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. Takes the lead in generation of GMP documentation and operator training.

• Involved in CAPA writing and implementation.

• Teaches junior engineers appropriate practices for addressing quality issues, including variances, activations, and other QA related documentation.

• Designs processes in current or future plant equipment using extensive plant and chemistry knowledge.

• Provides leadership in audits in the plant.

• Monitors and manages process performance.

• Conducts product changeovers, preparation of cleaning instruction, and leading in set up operations.

• Activates and qualifies facilities and equipment.

• Prepares new batch records and work instructions.

• Develops process training for all personnel.

• 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.

• Mentors less senior engineers for development.

• Communicates directly to management about process delays, issues, and improvements.

• Writes CEAs for process and plant improvements under direction from more experienced colleagues.

• Details process feedback to program managers and SLT.

• Provides input to the business plan and production plan.

• Experience in transferring technology from R&D scale to full scale production

Experience & Qualifications

• Typically requires 8-14 years of related experience and a bachelor's degree or 7-11 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 safety

• Strong attention to detail

• Team oriented

• Highly self-motivated

Physical Requirements

• Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
• Occasionally lift and/or move up to 10 pounds.
• This position may require up to 5% travel with occasional increase in travel demands based on business needs.

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