Associate Director, Change Lead for Enterprise Architecture (CTO) (Hybrid - Rahway, NJ) - Military Veterans

Job Description

Our Digital Manufacturing Operations organization supporting the vibrant West Point site is seeking a Senior Specialist in Process Automation to join the team.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and collaboration of individuals. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork.

As part of our team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

This role will lead a team of engineers in providing automation system support and expertise to enable our manufacturing division in the reliable and compliant supply of quality vaccine products to customers and patients across the globe.

Key responsibilities of this role include:

• Lead a team of 6 engineers in providing process automation support for our Building 60 biotechnology manufacturing facility to enable reliable and compliant manufacturing/ supply of vaccines.
• Direct/ prioritize workload activities of the process automation team, responsible for:
• Compliance with System Development Life Cycle (SDLC), GMP, safety and environmental regulations.
• Collaboration with other functions within the Integrated Process Team through ownership of automated systems and Subject Matter Expertise
• Support of manufacturing activities on the shop floor
• Design and implementation of process control improvements/ corrective actions
• Troubleshooting and resolution of automation issues/ events
• Participation in deviation investigations
• Administration of automated control systems, sustaining state of Permanent Inspection Readiness
• Apply leadership skills and sensibilities to foster a high performing, collaborative team environment
• Serve as primary Subject Matter Expert and represent automation function on IPT leadership team. Communicate daily with the business, technical and quality representatives through tier process
• Support process automation inquiries during internal and external audits/ inspections and must therefore be able to speak knowledgeably about automation in association with the cGMP processes and manufacturing operations
• Continuously evaluate automated systems and develop strategies to optimize and ensure quality/ stability of systems through future expansion, replacement, or upgrade.
• Directly support site and global initiatives with respect to digital transformation and improving how West Point Digital Manufacturing Operations does business

Education:

• Bachelor's of Science degree in Engineering, Computer Science or related field.

Required experience and skills:

• Technical and operational expertise in the following disciplines desired: DeltaV DCS, PLC, SCADA, HMI, Computer System Validation (CSV) and System Development Lifecycle (SDLC)
• Strong technical writing capabilities
• 7+ years in process automation, IT/ OT or equivalent
• Knowledgeable of S88 Batch Standard.
• Knowledgeable of regulatory GxP requirements.
• Knowledge of equipment and process validation
• Problem Solving (technical and non-technical)
• Strong communication and interpersonal skills to interface effectively with colleagues from all levels of the organization, and with external customers and vendors

Preferred experience and skills:

• Pharmaceutical and Biotechnology manufacturing process experience is strongly preferred.

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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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's 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 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".

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:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
12/20/2024
*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.