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North Carolina, United States
Onsite
Job Description
POSITION OVERVIEW – Basic Functions & Responsibility Essential functions include, but are not limited to:
The Senior Technician (Process), Operations role provides front-line process leadership, tactical direction, and subject-matter expertise for packaging operations. This role assists Operations Managers in coordinating line activities, resolving process and product quality issues, ensuring accurate production documentation, and driving continuous improvement to maximize line performance, product quality, and on-time delivery while ensuring compliance with cGMP and site procedures.
The Senior Technician (Process) will execute operations activities, including operate equipment, perform equipment setup, execute equipment challenges, monitor equipment performance and product quality during production, clean work areas, move materials accurately and efficiently, perform routine equipment/process troubleshooting, training, and issue resolution, on the assigned line(s).
This role serves as the primary process SME for assigned operations (e.g., In-process challenges and controls, Time Out of Controlled Storage (TOCS), Re-packaging, Batch Notes/MES Exception creation, among others), acts as the day-to-day escalation for process and quality questions, and partners with other areas to minimize downtime, reduce errors, and improve first-time quality.
This position requires strong leadership and communication skills, strong process knowledge and problem-solving skills, exceptional attention to detail, and the ability to drive correct decisions and corrective actions under time-sensitive conditions.
PRIMARY ACTIVITIES Primary activities include, but are not limited to:
• 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.
• Compliance
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.
• Collaboration and Teamwork
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.
SKILLS (include specific skill levels to apply Our Company's Leadership Principles):
a) Education Requirements
• High School Diploma or equivalent
b) Requirements
• 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 be willing and able to wear a respirator for short periods of time,
as required, and comply with all respiratory protection program
requirements.
c) Preferred Skills
• 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.
Required Skills:
Action Item Management, Action Item Management, Biopharmaceutical Manufacturing, Coach Team Members, Computer Literacy, Continuous Improvement, Continuous Improvement Initiatives, Corrective Action Management, Data Analysis, Documentation Preparation, Employee Scheduling, FDA Regulations, Good Documentation Practices, Good Manufacturing Practices (GMP), Master Batch Records, Material Selection, Operations Management, Packaging Operations, Pharmaceutical Process Development, Process Training, Production Management, Production Planning, Production Reports, Production Tracking, Regulatory Compliance {+ 9 more}Preferred Skills:
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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
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San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
3rd - NightValid Driving License:
NoHazardous Material(s):
NAJob Posting End Date:
11/7/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.