Manufacturing Supervisor (Blow Fill Seal)
|Monroe, North Carolina - United States
$55,000.00 - $75,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are actively seeking a Blow Fill Seal Supervisor, to join our growing team. Provide process supervision for the Blow Fill Seal qualification activities for a new facility. The successful candidate will serve as a technical resource in process development, process/equipment troubleshooting, process optimization/scale-up, and technology transfer. The candidate will supervise the day-to-day activities of production associates including Formulation, Filling, Inspection, Packaging, Labeling, and Sanitization and coordinate activities of support groups and communicate production priorities and progress to team.
- Review/Update current SOPs/batch records as well as write new SOPs/batch records, and protocols
- Assist associates with in-process testing to assure batches meet specifications
- Manage the performance of Production Associates and Leads
- Assist with the operation and maintenance of production equipment
- Lead troubleshooting and process improvement activities including corresponding documentation activities
- Initiate appropriate action when process deviations occur
- Reviews GMP documents (MBRs, SOPs, RM specifications, protocols) and generates change controls.
- Assist in writing proof of principle protocols, assist in writing and developing design specifications and IQ/OQ/PQ protocols
- Provides input in developing strategy and departmental business plan. Effectively manage Operations Associate performance and development to support company policies, procedures and goals
- Participate in RFT walk-throughs and objectives. Support projects and project teams as appropriate
- Responsible for achieving day-to-day process outcome and delivering process results. Thinks analytically to understand a situation or problem – makes metrics-based decisions
- Focus on efficiency of process, reduced changeovers, customer service goals, compliance, cost management and training
- Supports departmental budgets, efficiencies, and compliance metrics. Analyze the operations against Unit Fill Rate, Standard Operating Procedures (SOP’s), etc. to ensure compliance and proactively identifies gaps and presents solutions to resolve
- Support commissioning, qualifications, and validations activities by preparing protocols for IOQ/PQ, prepare summary and final reports for each equipment, systems, and process. Conduct gap analysis on systems, equipment, and give recommendations based on assessments
- Bachelor’s degree or advanced degree in Science, Engineering, or Pharmaceuticals.
- Minimum of 5 -7 years in formulation/process development, manufacturing support, scale-up, validation, and technology transfer experience required. Candidates with previous Blow Fill Seal experience and sterile manufacturing experience will be given preference.
Knowledge and Skills
- Project management skills; strong verbal and written communication skills
- Applied knowledge of root cause analysis and troubleshooting techniques. Able to apply statistical analyses and experimental design techniques. Technical competence and writing skills.
- Strong customer/quality focus.
- Knowledge of pharmaceutical GMPs and regulatory (FDA, DEA, OSHA) requirements
- Adherence to all health, safety, and environmental requirements
- Strong knowledge of 21-CFR-210, 21-CFR-211 and ICH Guidelines
- Very strong knowledge in FDA regulations, industry best practices, and FDA expectations.