Senior Technician (Process), Operations

o Assist Operations Managers with coordination of daily production activities to meet schedule adherence and customer requirements.

o Act as the process subject-matter expert (SME) for assigned operations (e.g., TOCS, Re-packaging, Batch Notes creation, etc.).

o Manage the accuracy and flow of critical production information.

o Perform visual inspections of products, packaging, and production areas during line clearance, in-process checks, repackaging, and material reintroduction. These tasks require distinguishing fine visual details, printed information, and product or component colors.

o Apply process knowledge to proactively identify potential production issues, takes action to prevent occurrence and/or communicate equipment-related issues to Maintenance and Engineering; provide accurate information to support troubleshooting.

o Use root cause analysis tools to identify true root causes for quality and safety events and support implementation of corrective and preventive actions.

o Provide SAP/MES operational support; resolve non-routine system issues and assist others.

o Work with MMS/Materials Management to resolve component issues and incoming quality concerns.

o Assist Operations Managers in determining root cause for line downtime impacting Schedule Adherence (SA) and delivery and support corrective actions.

Participate and/or lead (when needed) Tier meetings, act as liaison between shifts, teams, IPTs, and other areas to facilitate batch information flow and ensure actionable items are addressed.

o Support management actions coming out of Tier 1 meetings and escalating items to Tier 2 as required.

o Contribute to departmental financial goals by monitoring and helping control labor, component usage and material waste.

o Review line performance data and other system trends to identify issues and recommend actions to address, as appropriate.

o Participate in qualification, validation and technical documentation efforts as required.

o Ensure areas are maintained in top condition to support safe and efficient operations.

o Carry out Our Company's site mission by assuring finished goods and services are of the highest quality, optimal cost, and delivered on schedule.

o Conduct all manufacturing and packaging operations in accordance with current Good Manufacturing Practices (cGMP), site SOPs and divisional policies.

o Strictly adheres to all site policies on personal conduct and attendance.

o Perform and train staff online clearance and contamination prevention procedures to reduce risk of mix-ups or cross contamination.

o Take accountability for personal and others' safety by reporting and resolving unsafe conditions.

o Responsible for reviewing production batch documentation (electronic and paper) to ensure it is complete, accurate, and available.

o Responsible for expediting batch record issue resolution in collaboration with Quality and Operations Managers to ensure on-time batch release.

o Identify, raise, and assist with management of quality issues; support investigations and CAPA implementation with Quality, Maintenance and Planning.

o Initiate incidents in CLUE and/or participate in quality investigations.

o Participate in internal and external audits and inspections and ensure local readiness and compliance.

o Collaborate to develop, review and update SOPs, work instructions, forms and other batch-related documents as required.

o Coach team members in Good Documentation Practices/data integrity in all production records and on correct procedural execution and monitor adherence.

o Ensure personal and team adherence to health and safety policies, proper gowning, PPE and housekeeping standards.

o Lead and/or contribute to continuous improvement initiatives (5S, GEMBA, root cause analysis) to reduce deviations, human errors, variability and downtime while improving throughput and first-time

quality.

o Attend and actively participate in safety, quality and production-related improvement activities and proactively identify and execute improvement actions.

o Champion safety good catches and exemplify Safe by Choice behaviors, driving implementation of actions to mitigate identified risks.

o Train, coach and mentor operators: assess training needs, develop training materials and procedures, and act as primary train-the-trainer for key process activities.

o Demonstrate strong interpersonal skills, empowering leadership, conflict resolution, and the ability to lead team-based culture and performance improvement.

o Communicate effectively across shifts and functions; prepare and present technical findings, improvement proposals and investigation outcomes in a clear and concise manner.

o Collaborate with cross-functional teams to prioritize repairs and improvements and ensure timely communication of issues.

• High School Diploma or equivalent

• 4 plus years of experience in a GMP manufacturing facility.

• Minimum 3 years of leadership experience in a direct GMP manufacturing or packaging setting and/or prior experience in an Operations Technician (Process) role with demonstrated leadership

skills.

• Robust understanding of cGMP requirements related to manufacturing and packaging execution.

• Demonstrated ability to work with computerized and automated systems (SAP, MES, or equivalent).

• Demonstrated leadership ability including peer training experience and the ability to coach and develop others.

• Demonstrated experience in batch record execution and review and adherence to good documentation practices.

• Demonstrated experience with formal problem-solving techniques and hands-on approach (root cause analysis, Lean Six Sigma tools).

• Strong verbal and written communication skills; ability to influence and collaborate across shifts and functions.

• Must be able to lift up to 50 lbs.

• Must be willing to work irregular hours to support multi-shift operation and/or weekends as needed.

• Must pass a vision exam and be free of color blindness.

• Must be equivalent to 20/20 correctable close vision acuity.

• Must be medically cleared and physically capable of passing annual occupational health evaluations for respirator usage, including use of a PAPR (Powered Air-Purifying Respirator).

• SME-level experience in SAP, MES, PasEx, Tracksys, electronic logbooks, or other production execution systems.

• SME on the different operations process (Time Out of Controlled Storage, Re-packaging, Batch Note creation, etc.).

• Formal Lean/CI training and hands-on experience in implementing CI projects.

• Ability to support technical writing of documents such as standard operating procedures (SOPs)

• Demonstrated ability and drive to work autonomously and help organize priorities and work with other team members.

• Outstanding communication skills both within direct team and across multiple shifts to ensure success of overall team.

• Competencies/Leadership Behaviors: Empowering leadership; Flexibility; Motivation; Teamwork/Collaboration; Results-Oriented; Problem-Solving; Communication.

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The salary range for this role is: $63,800 - $100,400

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. 

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. 

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

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