Associate Director-Automation Engineer

Job Description

The Associate Director Manufacturing Automation in Digital Manufacturing Operations is responsible for management of all automation process control systems in a live virus bulk manufacturing facility, leading a team of automation engineers providing guidance and assistance for shop floor support, deviation investigations, change management, system administration, and management of small projects, and workload prioritization, technical oversight, and team development.

The successful candidate will have the opportunity to apply their passion, technical skills, and leadership skills as a member of a multidisciplinary team supporting vaccine manufacturing.

Key Functions

• Manage a team of automation engineers that provide process automation support to enable reliable and compliant supply of vaccines while achieving safety, quality, and environmental compliance.
• Establish priorities and work schedules with stakeholders (operations, technology, quality) and manage workload distribution for direct reports.
• Provide development plan and opportunities for direct reports through mentoring, on-the-job training, as well as official training.
• Lead and support in system upgrades, shop floor troubleshooting issues, identifying trends, process monitoring, system administration, documentation updates, data querying, operator training and participating in deviation investigations.
• Ensure automation documents, preventive maintenance, periodic reviews, and SOPs are in an inspection-ready state.
• Accountable for process automation inquiries during internal and external audits/inspections and must, therefore, be able to speak knowledgeably about automation, process and cGMP details of the manufacturing operations.
• Evaluate automated and information technology systems and develop strategies to optimize and ensure the quality and stability of automation systems through future expansion, replacement, or upgrade.
• Use their technical knowledge to assure the efficient operation of a variety of automated processing and information technology systems.
• Accountable for installation and qualification of new equipment into operations.
• Participate and contribute to investigations of automation anomalies to prevent a recurrence, which includes on-the-floor support of manufacturing activities.
• Accountable for the development of technical requirements, keeping in mind the associated technology needs, benefits, and risks.
• Analyze complex business requirements using tools and techniques and identifies internal/external solutions to meet these requirements.
• Accountable for developing control strategies and applying computerized tools that will deliver tangible improvements to overall production unit performance.
• Communicate daily with the business, technical, and quality representatives within the area of support through the tier process.
• Provide off-site weekend/evening automation phone or on-site support on a rotational basis.
• Familiar with lean manufacturing principles with an ability to convert business logic and requirements into detailed system/automation requirements.

Education:

• Bachelor's degree in engineering, Science, Information Technology or other relevant discipline.

Required Experience and Skills:

• Minimum Seven (7) years in pharmaceutical process automation or equivalent
• Experience in Automation Platforms such as DCSs (DeltaV), PLCs (Allen Bradley, Siemens), SCADA, Data Historians (OSI PI), Batch Reporting (Informetric InfoBatch)
• Demonstrated ability to communicate effectively and to build relationships with team, peers and other area leads.
• Demonstrated leadership in achieving shared objectives in a matrix organization.
• Strong understanding of manufacturing principles/ processes and ability to translate. manufacturing requirements into Automation/digital solution.
• Strong understanding of aseptic and sterile operation.
• Experience in all aspects of GMP Change Control and Computer System Validation.
• Proven track record of analytical skills, problem solving and attention to detail.

Preferred Experience and Skills:

• Experience with Computer System Validation.
• Experience working in a cGMP environment.
• Experience leading and managing teams.
• Networking, Virtual Machines, Database management and other general Information Technology administration.
• Experience in biologics, vaccine or bulk sterile manufacturing facilities.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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 presence. This 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".

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.

Job Posting End Date:08/16/2024

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.

Requisition ID:R307482