JOB SUMMARY
This position will manage and coordinate activities related to the new product launches: validation studies and process changes to support existing products and optimization of existing products/processes.
This role is responsible for understanding the company's and customers' technical needs; developing, defining and implementing short- and long-term technical service strategies to achieve company and customer needs.
Essential Functions
Prepare validation documents, review and execute; and identify opportunities to improve documentation practices and compliance
Manage product launches, manufacturing technology transfers to validation and manufacturing groups, process improvement
Transfer the technical knowledge of the process (by working with project scientist) to manufacturing
Participate in deviation investigations to identify root causes and define corrective and/or preventative actions (CAPA)
Provide life cycle management support to all existing products and processes, and enable execution of continuous improvement programs
Review batch production records and identify opportunities to improve documentation practices and compliance
Provide periodic updates to senior management on progress of projects, risk and mitigation plan
Ensure staff is adequately trained to perform job assignments. May identify and develop specific training content to support ongoing development efforts, supervise and/or mentor junior level engineers
Additional Responsibilities
Prepares batch records.
Change Controls, Planned Deviations.
Reviews APRs.
Understands new technology platforms and drug developments.
Completes statistical analysis.
Education
Bachelors Degree (BA/BS) degree in science, engineering, manufacturing technology or closely related field -Required
Master Degree (MS/MA)degree in science, engineering, manufacturing technology or closely related field -Preferred
Work Experience
4 years or more inPharmaceuticals/Chemical with BS -Required
Skills and Abilities
Advanced level oral and written communication skills with the ability to speak and write with clarity and structure. -Advanced
Ability to interpret and prepare technical reports/documents with clarity and ease of presentation. -Advanced
Proficient skill level using Microsoft applications, including Word, Excel & PowerPoint. -Advanced
Good subject knowledge and problem-solving skills required. -Advanced
Specialized Knowledge
FDA's validation guidelines & requirements.
Demonstrated knowledge and understanding of oral dosage formulation process, manufacturing processes and equipment.
21 CFR
Statistical analysis.
Thorough knowledge of cGMP guidelines, GLP Practices and regulatory guidelines.


Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity