Job Description Summary

The Sr. Process Engineer serves as main point of contact for manufacturing processes regarding safety, quality, and continuous improvement activities. Improves safety, quality, and productivity of a solid dose pharmaceutical operation. Consistently seeks for and evaluates methods to improve overall customer satisfaction through improved manufacturing efficiencies.

Job Description

ESSENTIAL FUNCTIONS:

• 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.

MINIMUM REQUIREMENTS:

Education:

BS degree in Industrial, Manufacturing, Chemical Engineering or related field.

Experience:

Five years of related experience in pharmaceutical industry. Solid dose production experience is preferred

Preferred Skills/Qualifications:

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

Other Skills:

Knowledge of cGMP regulations.

Excellent communication skills, both oral and written

Strong working knowledge of Microsoft Office products including Word and Excel

RELATIONSHIPS WITH OTHERS:

The Sr. Process Engineer supports the pharmaceutical manufacturing process and may be assigned a general plant support role. Position interacts with production technicians, production managers, project managers and Leadership team member, R&D, corporate engineering and external vendors.

WORKING CONDITIONS: Works an equal amount of time on the production floor in a manufacturing environment and an office type environment. The time spent on the production floor may be extended periods of time within a manufacturing facility

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.