Sr. Process Engineer

Endo•Fenton, MO

7d•Hybrid

About The Position

The Sr. Process Engineer serves as the main point of contact for manufacturing processes regarding safety, quality, and continuous improvement activities. This role focuses on improving the safety, quality, and productivity of a solid dose pharmaceutical operation, consistently seeking and evaluating methods to enhance overall customer satisfaction through improved manufacturing efficiencies.

Requirements

BS degree in Industrial, Manufacturing, Chemical Engineering or related field.
Five years of related experience in pharmaceutical industry.
Knowledge of cGMP regulations.
Excellent communication skills, both oral and written
Strong working knowledge of Microsoft Office products including Word and Excel

Nice To Haves

Solid dose production experience is preferred
Strong knowledge of chemistry, physics, and engineering principles.
Experience with manufacturing processes.
Ability to effectively communicate with all levels of the organization, from operations to senior management, both oral and written format

Responsibilities

Works closely with Research & Development (R&D) organization project managers and formulators for new product transfer into the facility.
Identifies and implements improvements to existing processes using continuous improvement tools.
Ensures that processes comply with all cGMP regulations in regards to process and cleaning validation.
Completes exception investigations and implements effective corrective and preventative actions.
Write and update batch records for new and existing product lines.
Ensures accurate completion of all paperwork and documentation including batch records, equipment, etc.
Design, validate and commission new production equipment and tooling, monitor modifications and upgrades, and troubleshoot existing processes.
Write and execute validation documentation (process, cleaning, and equipment) for new and existing product lines.
Regular participation in production daily operations meeting and lead team problem solving efforts.
Work with plant safety to maintain process specific safety information.
Assist in developing training programs and/or SOPs to enhance skills sets and reduce defects.
Support customer or regulatory agency audits as the subject matter expert for assigned processes.
Provide technical support and problem resolution.
Ensuring that process critical maintenance is completed in a timely manner to reduce downtime.
Candidate may also have to assist in production efforts when necessary.
Coordinate projects as assigned.
Perform other duties as assigned.