Process development engineer [h1.location_city]

Description

ESSENTIAL FUNCTIONS :

Studies process and equipment to identify problems and opportunities. Provides technical guidance and instruction to APAP Operations Team regarding troubleshooting and debottlenecking efforts.

Ensures that all processes operate within defined and validated limits.

Conducts training for APAP Operations Team on new equipment and process changes.

Represents the APAP Operations Team in developing and implementing capital projects. Activities include project scoping, operating requirements, process controls, process tolerances, alarm rationalization, and validation.

Prepares periodic reports that summarize production rate, yield, rework status, quality condition and that summarize any special projects or problems that have been encountered.

Identifies and implements changes to reduce product cost by increasing production rate, improving yield, reducing downtime, improving equipment efficiency, etc.

Participates in periodic process audits with management personnel with respect to safety, environmental, quality, production, and cost.

Generates, reviews, and updates documentation for managing the process, including operating reports, batch records, P&IDs, etc. Reviews operating reports and batch records for accuracy and improvements.

Participates in customer and regulatory audits.

Investigates process deviations, inquiries, complaints and equipment loss incidents and identifies corrective and preventative actions where needed. Coordinates implementation of corrective measures.

Actively supports site continuous improvement process and serves on teams as needed to improve the workplace and increase efficiency and productivity.

Other duties as assigned with or without accommodation.

MINIMUM REQUIREMENTS :

Must have a B.S. in Chemical or Mechanical Engineering

Must possess knowledge of chemical and chemical engineering principles in order to solve production, quality and throughput problems.

1-5 years of experience in chemical or bulk pharmaceutical (API) manufacturing operations

Understanding of GMPs (ICH Q7) and process validation

Understanding of Six Sigma and Lean Manufacturing tools and concepts

Experience in root cause analysis

Experience with change control / management of change

Demonstrated technical and leadership skills including oral / written communications, conflict resolution, decision making and sufficient financial acumen to interpret cost analyses and other reports

Ability to plan and execute tasks on multiple projects simultaneously

Must strive for continuous improvements in all work activities

Self-motivated, Action-oriented, Technical Skills, Problem Solving, Informing, Organizing

RELATIONSHIP WITH OTHERS / SCOPE :

The Production Engineer will report to the APAP Focus Factory Manager

The Production Engineer will work closely with the other APAP Sr. Production Engineers, Supervisors and Sr. Day Operator to coordinate tasks

Frequent interactions with the following functions will be required :

APAP production operators

QA and QC

Maintenance and Engineering

EHS

Periodic interaction / communication with all site departments and corporate groups

May work with outside engineering design firms, manufacturer's representatives, vendors, and construction contractors

WORKING CONDITIONS :

Works in an office environment, but will spend significant time in a multi-story bulk pharmaceutical (API) manufacturing plant that is partly outdoors

May be exposed to fugitive emissions of chemicals typical of chemical operations

Must be able to climb stairs and ladders for equipment installation review, monitoring and troubleshooting.

Must be willing and able to wear PPE including hard-hat, steel-toed shoes, safety glasses, earplugs, fire-resistant clothing and any other devices or equipment that may be required

Position is required to be periodically available for on-call nights / weekends

DISCLAIMER :

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

EEO Statement :

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.