To provide expertise in the process development; scale-up and product transfer functions related to pharmaceutical manufacturing operations
This position is considered full time (40 hours a week on average, sometimes more) position. Follows all policies, procedures, SOPs, cGMPs, Work Instructions, and supervisor instructions. This duty is performed daily, about 100% of the time.
To provide overall support in the safe and compliant manufacture of commercial pharmaceutical products. This duty is performed daily, about 100% of the time.
Define and assist in the development of manufacturing processes of pharmaceutical products. This includes process scale-up, product transfer, new product development and existing product and process improvement. This duty is performed weekly, about 50% of the time.
Troubleshoot process and procedural issues during the manufacturing operations. This duty is performed weekly, about 50% of the time.
Generate, edit and issue master batch documentation (MBRs) for process, equipment and cleaning activities. This duty is performed weekly, about 30% of the time.
Investigate deviations and variances in both manufacturing and packaging. Generate deviation reports and identify long term corrective and preventative actions. Assure implementation of such solutions in a timely manner. This duty is performed weekly, about 30% of the time.
Lead and assist in all technical process enhancements and ancillary activities such as but not limited to: Process and equipment validation, implementation of new equipment, changes to existing manufacturing process, etc. This duty is performed weekly, about 30% of the time.
Lead and assist in demonstration/scale up/pilot batch manufacture, engineering studies, equipment upgrades, etc. This duty is performed weekly, about 30% of the time.
Identify and suggest process, equipment and efficiency improvements in the operational area. This duty is performed weekly, about 20% of the time.
Prepare and present training presentations for technical training of operations personnel. This duty is performed weekly, about 20% of the time.
Review executed batch documentation as needed. This duty is performed weekly, about 10% of the time.
Work in multi-functional teams (Validation, QA, QC, SCM) to enhance and facilitate overall operational success. This duty is performed weekly, about 50% of the time.
Perform any other related duties as required or assigned.
To perform this job successfully, an individual must be able to perform each essential duty mentioned satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Four year technical degree (I.E. bachelors) or equivalent experience required in such fields such as engineering, science (Chemistry, Biology), etc,
7 years Pharmaceutical manufacturing experience and/or training. (Or equivalent combination of education and experience).
Oral liquid pharmaceutical experience preferred.
This position does not offer sponsorship
Equal Opportunity Employer
Minorities / Females / Protected Veterans / Individuals with Disabilities
MAU Workforce Solutions staffs excellent, effective people for their partners, allowing them to focus on their core competencies. Headquartered in Augusta, GA since 1973, MAU is a family-owned, minority company making lives better for applicants, clients, and employees through innovative workforce solutions. Today, with Branch and vendor on premise locations across the South and recruiting partners worldwide, MAU has global capabilities to help with all staffing, recruiting, and outsourcing needs.
Location/Region: Greenville, SC (US)