Associate Director, Automation Engineering

**Job Description** **Primary Responsibilities:** + Maintain and support facility automation and controls to ensure robust operation and compliance with GMP, safety, data integrity, and current regulatory expectations + Provide automation leadership for GMP clinical manufacturing campaigns and pilot plant operations, including ongoing system support and troubleshooting + Manage, develop, and grow a team of 8-10 OT/Automation engineers; oversee objectives, employee development, resource planning, and budget preparation + Lead design, scoping, implementation, and GMP closeout of pilot plant projects; specify and integrate automation for new equipment, upgrades, and improvements + Serve as the site automation representative for new capital projects; initiate and provide resources for technical support, and direct coordination of startup, commissioning, qualification, and validation activities + Collaborate with IT, GES, OEMs, and cross-functional teams to evaluate and implement new technologies and automation systems that improve reliability, efficiency, and performance + Receive assignments, direction, and technical guidance from leadership and/or Pharmaceutical Sciences colleagues; actively contribute within multidisciplinary, cross-functional teams and cross-train across areas and technologies + Author, review, and approve GMP procedures and documentation, including SDLC/CSV deliverables, engineering drawings, change controls, SOPs, test protocols, safety reviews, and deviation investigations/actions + Develop and execute qualification and validation plans for automated computer systems; prepare and approve protocols and summary reports; execute commissioning and decommissioning + Facilitate and participate in QN reporting, investigations, and CAPA; support QMS activities, periodic reviews, and equipment/system changes + Solicit, share, and implement best practices with peers; promote continuous improvement and reliability maintenance best practices + Exercise objectivity in reporting findings; demonstrate cooperative, responsive collaboration; uphold personal and workplace safety + Maintain strong knowledge of cGMPs, financial principles, QA policies, safety guidelines, data integrity guidelines, engineering standards, and regulatory requirements; provide technical, project management, and systems leadership **Education Minimum Requirement:** + BS in Engineering Science, or Information Systems, plus a minimum of 7 years of related technical support or manufacturing automation experience or acceptable related experience. **Required Experience and Skills** : + Highly motivated, adaptable, and effective in fast-paced, dynamic environments; able to work independently and as part of a team + Strong leadership, project management, organizational, and communication skills; proven ability to mentor individuals and influence cross-functional groups + Demonstrated technical proficiency and troubleshooting across mechanical, electrical, and automation domains; experienced supporting capital projects + Prior automation experience in GMP pharmaceutical/biopharmaceutical/vaccine operations, including executing GMP change controls and adhering to Quality, cGMP, Safety, Environmental, and data integrity policies + Significant hands-on experience in one or more automation technologies, including PLCs (e.g., Allen-Bradley, Siemens) and SCADA (e.g., iFIX, WinCC OA, Ignition) + System administration and lifecycle management for automated and digital systems: Programmable Logic Controllers (PLCs), Supervisory Control and Data Acquisition (SCADA) and Batch operations aligned to S88/S95 + Information Technology (IT) infrastructure/interfaces + Ability to flex and "flow to the work," supporting both Quality and Facility needs to meet business priorities **System administration and management of the following automated systems:** + Programmable Logic Controllers + Supervisory Control and Data Acquisition systems + Distributed Control Systems + Batch Operations (S88/S95) + Manufacturing Execution Systems + Information Technology + OEM equipment. **Preferred Experience and Skills:** + Able to work independently and lead or facilitate tasks; manages work directly or indirectly through projects + Strong understanding of business impact and prioritization of technical initiatives; experienced in building and planning technology roadmaps + Experienced with project management methodologies (Agile, Waterfall) and tools (MS Project, RACI, Gantt) + Hands-on experience with manufacturing equipment and process control; automation infrastructure design and cybersecurity awareness + Skilled in integrating equipment automation with enterprise IT systems (MES, virtualization, networking) and managing Windows/antivirus patching and updates + Experience supporting GMP audits. **Required Skills:** Accountability, Accountability, Analytical Thinking, Budget Formulation, Business Management, CAPA Investigations, Communication, Cross-Cultural Awareness, Data Integrity, Deviation Management, Driving Continuous Improvement, Engineering Principle, Engineering Standards, Environmental Safety, General Safety, GMP Compliance, Maintenance Supervision, Manufacturing Quality Control, Manufacturing Scale-Up, Multidisciplinary Collaboration, Multi Disciplinary Design, People Leadership, Pilot Plant Operations, Professional Engineering, Project Management {+ 5 more} **Preferred Skills:** 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 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: 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 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". The salary range for this role is $139,600.00 - $219,700.00 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. More information about benefits is available at . You 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:** Regular **Relocation:** Domestic **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Job Posting End Date:** 11/27/2025 ***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:** R373748