Sr. Spclst , Manufacturing Automation (Rota POD IPT Lead)

Job Description

Senior Specialist Manufacturing Automation (Rota POD IPT Lead):

Responsible for working both as an integrated process team lead (IPT) and as a technical subject matter expert that will enable Our Company to deploy and operate a one-of-a-kind facility with a full end to end process consistent with global business processes common global information and IT supporting projects / application / technology suite. This position requires knowledge and experience in own discipline while still acquiring higher-level knowledge and skills. The position will build knowledge of the company processes clients/customers and will solve a range of problems while providing possible solutions. This position may often work autonomously with a moderate level of guidance and group work applies team effectiveness skills listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals. The lead will provide key automation support for various utilities/manufacturing/packaging systems such as PLC DCS MES IT and OEM systems in Manufacturing Operations as well as IT supply chain MES and PI/RtReport systems. The individual will work across all phases of the building (qualification and run/operate) and report progress to goals/changes identify key risks and mitigation strategies provide direct support for other process teams support deviation management and complete other duties as needed or assigned. Responsible for resolution of significant automation issues and maintainance of automation systems in compliance with cGMPs SLC safety and environmental regulations. Provides guidance on process control data collection techniques and failure mode and effects analysis. Develops strategies to optimize and ensure quality and stability of automation systems though future expansion replacement or upgrade. Supports preparation of digital/automation cost information to support necessary plans. Lead automation related investigations into Atypical Production Reports (APRs) and implement the corrective actions. Group supports a large spectrum of sophisticated automated systems within Manufacturing Operations; providing multiple opportunities to learn new automation technologies and make a positive impact. Responsibilities include providing automation leadership/support on limited shifts/weekend in support of Manufacturing Operations. Responsibilities may include coaching responsibilities and management of contract resources.

Primary Activities:

• Leads and provide key shopfloor support for various manufacturing systems such as PLC DCS MES IT Inspection Serialization and OEM systems within Manufacturing Operations. Serves as interface between operations and other digital support organizations to resolve issues impacting shopfloor operations. Collaborates with Operations Quality Maintenance and other Technical groups to resolve complex problems and provide innovative solutions. Participates in daily tier meetings and governance processes as necessary

• Leads qualification activities for packaging suite and works with stake holders to ensure timelines are met and risk are escalated.

• Provides direct support of validation activities and other associated Quality functions required. Develops and maintains technical documentation as necessary. Participates in audit and training programs in area of responsibility.

• Evaluates automated and information technology systems and develops strategies to optimize and ensure quality and stability of automation systems through future expansion replacement or upgrade. Identifies and implements process/equipment improvements and manufacturing efficiencies. Provides guidance on process control data collection techniques and failure mode and effects analysis. Prepares automation cost information to support necessary plans.

• Understands and supports all GMPs safety and environmental regulations. Maintains shopfloor systems in compliance with SLC cGMPs safety and environmental regulations. Provides leadership in the analysis of system data integrity requirements and system security. Periodically authors and reviews system documents preventive maintenance and SOPs to ensure compliance with GMP and safety. Participates in audits and training programs as SME in appropriate areas of knowledge and responsibility.

• Responsible for recognizing and addressing irregularities in shopfloor systems and automated equipment. This involves troubleshooting issues devising solutions and implementing measures to rectify or prevent these atypical shopfloor system incidents leads/supports investigations to determine root cause. Formulates and supports corrective measures to prevent recurrence. Addresses compliance requirements to document investigations and corrective actions.

• Manages shopfloor system project activities following approved business processes to deliver results that are quality engrained right first time on-time with schedule requirements reconciled to the budget and meet all Quality/Safety requirements. Deliver project plans which have been developed and aligned with all key stakeholders. Lead projects by engaging team members setting clear expectations utilizing strong communication skills and exercising clear decision-making. Regularly and clearly communicate project plans risks and strategy to all key stakeholders customers and governance committees. Prepares automation cost information to support necessary project plans.

• Educates teammates and colleagues on manufacturing computer systems to ensure the efficient operation of various automated processing and information technology systems. This involves sharing knowledge on engineering principles and other areas of expertise as needed serving as a subject matter expert for shopfloor control systems creating knowledge-based problem resolution articles to share with colleagues coordinating applicable training events and proactively sharing knowledge and experiences.

• Responsible for providing subject matter expert knowledge for new and existing equipment following current regulatory change controls and qualification requirements approach.

• Manage repository for production equipment/system qualified automation programs and files with associated metadata.

• Responsibilities may include providing coaching leadership to other team members while exhibiting appropriate Leadership standards. May manage selected external contractors - monitoring performance and ensuring contractual obligations are met.

• Role requires limited off shift/weekend support and participation in an on-call rotation.

Skills

Education Requirement:

• B.S. B.A or M.S. in Information Technology ScienceEngineering or related technical field.

Required Experience & Skills:

• Minimum of eight years experience in IT/Automation support of manufacturing or process engineering or equivalent.

• Working knowledge of the regulatory requirements for pharmaceutical applications.

• Working knowledge of PLCs HMIs Servo-Drives and Control Systems.

• Effective leadershipinterpersonal and communication skills (written and oral) are required.

• Experience in computer validation and systems lifecycle development methodology.

• Experience authoring and reviewing standard operating procedures on-the-job-training and other controlled documents.

• Demonstrated ability to lead key projects across multiple site disciplines.

Desired:

• Highly desired are skills inpackaging technology equipment Vision Systems barcode systems reject/verification processes Serialization MES IT OSI PI/RtReports and OEM equipment.

• Experience with Continuous Improvement Lean Manufacturing Problem Solving and Right First Time methodologies.

• Data Integrity and Cyber Security acumens are desired.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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 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:

EEOC Know Your Rights

EEOC GINA Supplement

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 anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

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. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

Search Firm Representatives Please Read Carefully
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: