Back-up Section Leader - Manufacturing

Overview Assists the Supervisor and leads the Manufacturing department daily to ensure safety, quality, and high productivity while fostering a positive work environment. Plans and communicates production needs, manages overtime, trains new hires, and serves as a subject‑matter expert for R&D initiatives. Keeps the supervisor informed of all shift‑related issues. Job Responsibilities Assign qualified personnel to meet the weekly production schedule, including overtime scheduling. Ensure personnel are properly trained and qualified before task assignment. Conduct daily and batch reviews of documentation for accuracy and completeness. Monitor and document critical process parameters during manufacturing. Investigate process problems, notify Supervisors, and implement corrective actions. Execute batch processing steps per Batch Record and labor standards to produce quality products safely and efficiently. Verify raw materials against issuance documents. Print in‑process labels for manufacturing in SAP. Assemble, disassemble, and clean equipment per GMP procedures. Collaborate with Quality Assurance and Engineering to meet quality specifications. Update Manufacturing DLM boards with current information. Monitor production schedules, troubleshoot and resolve problems. Report process‑related issues for appropriate action. Enforce GMP dress code standards and hold personnel accountable. Maintain housekeeping and 5S standards during the shift. Engage engineering support teams to resolve issues. Follow safety policies to prevent injury. Conduct training and re‑training of employees. Backfill associates in processing rooms as needed. Train and audit production employees on SOPs. Support Environmental, Health & Safety initiatives and ensure compliance. Perform other duties to meet production schedules or comply with cGMPs. Collaborate with the team to achieve all outcomes. Operate in accordance with the Code of Conduct, Business Ethics, and regulatory requirements. Support corporate values: Innovate, Evolve, and Excel. Sustain area housekeeping/5S initiatives and perform all other relevant duties. Qualifications Education: High school diploma or GED. Experience: 10+ years in fast‑paced, lean manufacturing/packaging within a GMP environment (pharmaceutical or food manufacturing); Transdermal manufacturing/packaging experience preferred. Demonstrated career progression within Aveva, with at least 3 years as a Back‑up Section Leader or equivalent experience. Knowledge, Skills & Abilities: Strong leadership, coaching, and manufacturing expertise; comprehensive understanding of cGMPs, safety, environmental, and security protocols. Proficiency with computer systems (JDE, web navigation, email, MS Word, MS Excel). English reading and writing proficiency for policies, SOPs, batch records, and cleaning procedures. Effective oral communication skills in English. Basic mathematical ability for multi‑level/complex formulas, and adherence to rounding and significant‑figure rules. Problem‑solving skills to address variable‑related issues in standardized situations. Data gathering and GMP investigation support skills. #J-18808-Ljbffr Aveva Drug Delivery Systems