Manufacturing Process Engineer

Located in Texarkana, TX

Salary: $20.00

 

Position: Manufacturing Process Engineer

Location: Texarkana, TX

Pay: $20.00

Shift: Day shift 

Benefits: Full benefits package offered

 

 

GENERAL DESCRIPTION OF THE JOB:

The Manufacturing Process Engineer will aid in Quality Assurance efforts to ensure compliance with established quality standards. This individual will implement and refine procedures to enhance operational efficiency and ensure processes meet regulatory and internal quality expectations. In addition, the Manufacturing Process Engineer will conduct investigations into any Out of Specification (OOS) events and deviations identifying root causes and implementing corrective and preventive actions.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Process Development: Develop Master Job Directions by collaborating with the Product Development team to scale up manufacturing processes, ensuring they are optimized for quality, efficiency, and compliance in a production environment.

 

Validation Process: Develop, execute, and oversee validation protocols for the batching process to confirm that equipment, processes, and procedures meet regulatory and quality requirements. Document and analyze validation results, implementing any necessary adjustments to achieve consistent and compliant production outcomes.

 

Bulk Hold Studies: Develop and execute bulk hold studies to determine appropriate storage conditions and duration for bulk materials, ensuring product stability and quality are maintained throughout the holding period. Document findings and implement holding guidelines that support consistent quality and compliance.

 

Execution Verification: Issue and oversee the execution of Batch Records, Master Job Directions, and Master Cleaning Directions within Production, verifying adherence to documented processes and investigating any deviations from protocol.

 

Interdepartmental Collaboration: Collaborate with the QC Lab and Production Department to ensure timely sample collection, testing, and reporting.

Investigations: Lead root cause analysis for Out of Specification (OOS) events and deviations, coordinating corrective and preventive actions as necessary.

Training and Support: Provide guidance and support to Production personnel to ensure understanding and compliance with quality standards by training them on quality protocols, document handling, and the importance of adhering to Standard Operating Procedures, fostering a culture of quality and accuracy.

 

Continuous Improvement: Analyze existing processes to identify areas for improvement, implementing changes to enhance efficiency and process reliability while maintaining quality compliance.

 

General Responsibilities: Plan, coordinate, and implement necessary changes for each program, ensuring alignment with quality and regulatory requirements. Oversee process adjustments and support continuous improvement initiatives. Perform additional duties as assigned to uphold production and quality standards, contributing to a compliant and efficient manufacturing environment.

 

 

 

QUALIFICATIONS:

• Quality and Regulatory Acumen: In-depth knowledge of cGMPs, FDA regulations, and industry standards in OTC drug manufacturing, with experience ensuring quality and regulatory compliance in production processes and documentation.
•  Process-Focused Problem Solving: Demonstrated ability to approach production challenges with a systematic, solutions-oriented mindset. Skilled in analyzing processes, identifying root causes, and implementing logical, data-driven improvements to enhance efficiency, quality, and consistency.                                                  
• Analytical and Investigative Skills: Strong analytical skills with the ability to conduct thorough root cause analyses, identify trends, and develop effective corrective and preventive actions (CAPAs) based on findings and observations.
• Attention to Detail and Prioritization: Detail-oriented with the ability to prioritize tasks and manage multiple projects simultaneously in a fast-paced, dynamic environment. Capable of adjusting priorities to meet changing business needs without compromising quality.
• Cross-Functional Collaboration: Demonstrated experience working collaboratively across departments, such as Quality Control, Product Development, and Production, to drive quality initiatives, resolve issues, and implement process improvements.
• Technical Writing and Documentation: Extensive experience in drafting, editing, and reviewing technical documents, such as Batch Records, SOPs, validation protocols, and investigation reports, ensuring accuracy, clarity, and compliance with regulatory standards.                                                
• Independent and Cross-Departmental Problem Solving: Capable of working independently to conduct internal investigations, gather research, and solve problems, while also effectively collaborating with cross-departmental teams to drive solutions.
• Continuous Improvement Focus: Strong commitment to process improvement, with a demonstrated ability to proactively identify opportunities for efficiency, quality enhancement, and risk mitigation.                                                                                                                        
• Communication Skills: Proven ability to communicate effectively both verbally and in writing, with experience presenting technical information clearly to various audiences, including cross-functional teams, production staff, and management.                                                                        
• Project Management and Organizational Skills: Skilled in project planning and execution, with experience managing timelines, coordinating resources, and driving projects to completion within established deadlines.

 

EDUCATION / TRAINING:

Bachelor’s degree in science (Biology, Chemistry or Engineering) is preferred.

A combination of experience in Quality Assurance.

 

PERFORMANCE STANDARDS:

This job must be performed with a low level of supervision, and/or direction from the Validation Manager in a way which will ensure a safe and quality finished good product in conjunction with complete compliance with cGMP process. Good job performance will include the initiative to do work and solve routine problems before being so directed, and to consult with management or other applicable resources as necessary. The position may require evening and/or weekend work on short notice. Duties must always be conducted in a professional manner, and all personnel must be treated with courtesy and respect.  A positive attitude with a willingness to embrace new challenges is key. Punctuality and attendance is required subject to Pharma Nobis Attendance & Tardy policies, in conjunction with corrective counseling (up to and including termination).

 

PHYSICAL DEMANDS:

This position requires sitting, standing, walking, reaching, stooping, and the use of both hands along with lifting up to 40 pounds while bending and twisting of the upper body.  Specific vision abilities include the use of continual reading from a computer monitor for long periods of time.

 

ENVIRONMENTAL DEMANDS:

This position requires frequent observation of production processes, which may involve working around elevated noise levels, machinery with exposed moving parts, and potential dust or chemical hazards. Company provides earplugs and other personal protective equipment (PPE) to ensure employee safety. While a portion of the role involves developing processes and protocols on a computer, time spent on the production floor to monitor and assess workflow is essential. If direct contact with any product is required, Safety Data Sheet (SDS) information will specify appropriate PPE.

 

BEHAVIORAL SKILLS:

Ability to make decisions and set priorities to include recognizing important elements of the job, estimating time needed to perform tasks, and drawing conclusions about problems/situations based on provided facts as needed to identify problems and recommend actions for solutions, schedule work for self and others, work without direct supervision, and respond to emergency situations. Ability to interact with supervisors, co-workers, and the public while remaining calm and courteous.  Being open to and sharing ideas as needed when conducting investigations, handling complaints, or performing investigations in other rare, ambiguous situations while abiding by policies and procedures and maintaining good company relations is necessary. All employees will follow and uphold policies as set out and signed in the Pharma Nobis Employee Handbook.

 

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