Assists Supervisor and provides daily leadership to employees in the Manufacturing department to ensure safety and quality, maximizing productivity and efficiency while fostering a positive work environment. Plans and communicates daily production needs within the team. Leads manufacturing teams on all assigned job duties, communicating overtime needs, training of new hires, and helping R&D with new processes as Subject Matter Expert. Keeps the supervisor informed of all issues that occur on the shift.

Job Responsibilities:

• Assigns qualified personnel as required to meet weekly production schedule including overtime scheduling as needed.
• Ensures personnel are properly trained and qualified before assigning tasks.
• Perform daily review of batch documentation for accuracy and completeness. At the end of the batch reviews all batch documentation for accuracy and completeness prior to submitting batch for review.
• Ensures Operators monitor and document the critical process parameters during the manufacturing process.
• Investigates process problems, notifies Supervisors, and takes appropriate corrective actions.
• Performs batch processing steps in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product.
• Verifies the correctness of all raw materials against the appropriate issuance documents to ensure that the correct materials are used during the manufacturing process.
• Prints the required in-process labels for manufacturing processes in SAP.
• Assembles, disassembles, and cleans equipment used for manufacturing in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment.
• Works with Quality Assurance and Engineering to ensure the manufacturing process meets quality specifications.
• Collaborates with Supervisor to ensure that the Manufacturing DLM boards are updated timely and reflect current information.
• Monitors production schedules, troubleshoots and solves problems.
• Supervisor of all process-related problems so that appropriate action can be taken.
• Complies with and enforces GMP dress code standards in order to minimize cross contamination, holding personnel directly accountable for compliance.
• Ensures housekeeping standards are followed and area is maintained during shift.
• Contacts engineering support teams as needed to address issues.
• Follows all departmental and company safety policies in order to prevent injury to self and others.

• Conducts training of new employees, new positions, processes, and retrains as necessary. 
• Backfills associates in the processing rooms as needed.
• Trains and audits production employees to ensure current approved SOP’s are followed.
• Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations.
• Performs other duties in order to meet department's production schedule or to comply with cGMPs.
• Works as a member of the team to achieve all outcomes.

• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of our corporate values: Innovate, Evolve and Excel.

• Ensures area housekeeping / 5s initiatives are sustained, and all other relevant duties as assigned.

Job Requirements

• Education

• High school diploma or general education degree (GED).

• Experience
  • 10+ years experience in a fast-paced lean Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required. Transdermal Manufacturing/ Packaging experience preferred.
  • Demonstrate career progression within Aveva with a minimum of 3 years experience as a Back-up Section Leader, or equivalent related experience.