Pharmaceuticals Process Validation Engineer II

Validation

• Must be a self-starter and self-motivated and able to work perform primary tasks with minimal supervision.
• Write, review, and approve batch records, validation documentation and validation studies and reports on solid dosage forms including tablets and capsules and liquid dosage forms including solutions and suspensions in accordance with FDA regulations/guidelines.
• Lead manufacturing process validations, process capability studies and process improvements, provide leadership to QE personnel and technicians.
• Review, analyze and assess executed data and generate necessary summaries and validation/qualification reports. 
• Initiate change controls, investigations, deviations and CAPA with minimal supervision.
• Lead investigations to solve manufacturing or packaging problems or customer complaints, determine root cause and/or preventative actions, trend and report data with minimal supervision.
• Implement product validation, coordinate special studies or investigations while maintaining  project timelines and commercial product shipment dates.
• Design engineering/special studies on new and existing manufacturing processes toward optimization and/or improvement to ensure efficiency, effectiveness and compliance.
• Lead product transfer and scale up batches for filed and non-filed products through transfer to manufacturing and packaging to validation and analysis testing. 
• Interpret analytical data and trends with minimal supervision.
• Design and perform installation and operational qualification for manufacturing and packaging equipment including USP Purified Water system.
• Provide routine reporting to management on observed trends in process and product quality, investigation, and CAPA as necessary.
• Lead packaging study to establish critical parameters during packaging operation of solid/liquid products.
• Review and approve production records for Proof of Concept/experimental, Pilot/Registration, and commercial batches.
• Lead quality efforts into new product teams (ANDA/NDA) to ensure smooth transition of high quality standards.
• Consult with and influence R&D, Manufacturing, Quality, and clients to initiate product quality improvements.
• Help train new Quality Engineers to write and execute manufacturing/packaging records and protocols, change controls, SOPs, IQOQ, Investigations, Deviations, and CAPAs.

SKILLS NEEDED:

• Must have experience in pharmaceutical sciences, preferably the development and/or manufacturing and packaging of solid and liquid oral dosage forms, primarily tablets, capsules, solutions and suspensions.  Knowledgeable in all areas of manufacturing solid dosage forms including dry blending, granulation, milling, tableting and tablet coating.
• Must have excellent problem solving skills.
• Strong analytical skills with an ability to use scientific knowledge and statistical methods to identify issues and assess acceptability of system and process performance.
• Must have strong technical writing skills.
• Strong communication, organization and time management skills are necessary.
• Ability to prioritize work per business needs in a fast-paced environment.
• High degree of accuracy and attention to details.
• Ability to make decisions based on expertise and customer/business requirements.
• Ability to perform essential functions and responsibilities with minimal supervision.
• Proficient in MS Word and MS Excel.
• Excellent interpersonal skills, team work oriented with a positive attitude.

EDUCATION/TRAINING:

• Bachelor’s Degree in Engineering, Process Engineering, Pharmaceutical Science, Science, or equivalent work experience related to formulation and/or manufacturing and packaging of solid and liquid oral dosage forms.
• 5+ Process, Engineering, Formulation Development, Manufacturing, Quality or Tech Services related to the Pharmaceuticals, specifically to solid and liquid oral dosage forms.
• Possess a working knowledge of pharmaceuticals manufacturing of solid and liquid products or related field.
• Working knowledge and experience in various validation disciplines (process, equipment, facilities and cleaning validation), and current validation trends and processes desired.

PHYSICAL DEMAND/WORK ENVIRONMENT

Job requires standing and sitting as needed.  Walking, primarily on a level surface, periodically throughout the day is also required.  Reaching above shoulder height, below the waist and/or lifting may be required to file documents or store materials throughout the workday.  Proper lifting techniques required.  Activities may include occasional lifting up to 50 pounds for files, computer printouts and other mostly office related items.

The performance of this position occasionally requires exposure to manufacturing areas where, under certain circumstances, personal protective equipment such as safety glasses with side shields and hearing protection  and/or a PAPR are mandatory.  The primary environment will be ambient room temperature, office lighting and exposure to traditional office equipment as found in a typical office environment.