General Purpose of Position:
Provide support to Preventive Action (CAPAs), Technical Services and Engineering, and On-going Manufacturing efforts in terms of quality and efficiency of the 3DP process.
Primary Duties and Responsibilities (Essential Functions):
1 Develop and maintain databases, which provide trending capability for critical process parameters (CPPs).
2 Through periodic review of database and trends, identify opportunities for improvement in performance in process, labor effectiveness and efficiency.
3 Identify unfavorable trends and investigate root cause as well effective preventive actions (CAPAs).
4 Provide leadership and manufacturing support in investigations as assigned. Troubleshooting of issues and non-conformance items.
5 Support manufacturing management in assuring effective preventive actions (CAPAs) are identified and implemented in a timely manner.
6 Perform process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes.
7 Act as the manufacturing liaison in project planning and coordination within Technical Services.
8 Develop and implement SOPs in support of new and upgraded processes.
9 Develop and implement effective training of manufacturing personnel related to technical transfer and process upgrades. Implement job aides and manufacturing efficiencies to improve repeatability and consistency of the 3DP process.
10 Champion projects as they move into and through the manufacturing areas.
11 Support of manufacturing management in periodic review of existing and new revisions to manufacturing documentation in regards to (but not limited to ): Operability, Technical accuracy (technical reviews), Compliance, Process Robustness, etc.
12 Provide support to Management in revising and authoring GMP documentation as assigned
13 Provide administrative support to Technical Services and manufacturing in authoring and reviewing validation, production trial records, Technical Services Investigational protocols (i.e. Engineering Studies/White Papers) documentation as assigned
Reporting to this Position
No direct reports
Position may require 10-25% travel
Days 1st shift. Responsibilities for this role may be covered across multiple shifts
Knowledge, Skills and Abilities:
• Experienced manufacturing, process development, or engineering in a pharmaceutical setting
• Needs to have a blend of both technical and operational skills
• Dependable, well organized, efficient worker with good communication skills
• Statistical analysis and management of data
Education and Experience:
• BS degree in Math or Science field preferred
• Certification in Six Sigma Improvement methodologies or equivalent desired
• 10+ years in cGMP pharmaceuticals required
Physical Demands and Work Environment:
• Good eyesight to read, interpret, and create technical materials
• Good manual dexterity to operate computer and other general office equipment
• Sitting at a desk or standing for extended periods of time
• Occasional lifting of boxes (up to 25 pounds) containing engineering materials, manuals, tools, etc.
• Exposure to odd body positions (i.e. twisted torso, bent over position, etc.) for brief periods of time, while completing validation work in the laboratories or manufacturing areas taking samples, documenting batch information, etc.
• Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, safety shoes, safety glasses, etc.) Uniforms, gloves, hairnet, and moustache cover and barrier outerwear is required within the manufacturing area
• No facial hair other than a moustache is allowed for individuals in this position due to respirator fit issues
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.