Manufacturing Automation Managerof Lab Digital Support Operations

CareerCircle
San Francisco, United States of America
yesterday

Role details

Contract type
Temporary contract
Employment type
Full-time (> 32 hours)
Working hours
Regular working hours
Languages
English
Experience level
Intermediate
Compensation
$ 184K

Job location

Remote
San Francisco, United States of America

Tech stack

Computer Security
Data Systems
Digital Technology
Laboratory Information Management Systems
Commercial Software
Systems Development Life Cycle
Service Pack
Software Engineering
System Testing
Enterprise Software Applications
Real Time Systems
Information Technology
Data Management

Job description

The Manufacturing Automation Managerof Lab Digital Support Operations is responsible for leading a team of FTEs and contractors, delivering high-quality IT support for lab operations at our company. This role oversees team development, performance management, and strategic goal setting, ensuring alignment with both site and corporate objectives. The ideal candidate will combine technical expertise with strong leadership and communication skills, fostering a culture of continuous improvement, diversity, and inclusion within the Lab IT team., * Leadership & Team Management:

  • Lead, mentor, and develop a team of FTEs and contractors, fostering a culture prioritizing diversity, inclusion, safety, quality, and compliance.
  • Build strong collaborative relationships between Lab IT and other departments including QC and Manufacturing.
  • Provide clear direction, establish high standards, and assess team performance to deliver top-tier Lab IT support.
  • Conduct regular performance evaluations and provide constructive feedback to team members.
  • Strategic Planning & Goal Setting:
  • Establish goals and KPIs for the Lab IT team, ensuring alignment with QC, manufacturing, site and corporate objectives.
  • Drive continuous improvement initiatives across the Lab IT landscape to achieve year-on-year productivity gains.
  • Identify opportunities for process improvements and lead initiatives to enhance operational efficiency.
  • Collaborate with off-site Value Teams (VTs) to prioritize and deploy initiatives that improve digital maturity in lab operations.
  • Operational Excellence & Issue Resolution:
  • Monitor key metrics and ensure timely closure of safety, quality, and compliance actions, including QNs, CAPAs, and Change Controls.
  • Ensure audit readiness for lab IT systems, particularly in areas related to quality metrics.
  • Develop and manage budgets, maintaining operational efficiency.
  • Technology Integration & Reliability:
  • Collaborate with the business to ensure all lab equipment purchases align with IT standards and integrate seamlessly with our company infrastructure.
  • Maintain Lab IT systems' reliability, enhancing efficiency through technology.
  • Oversee Lab system validation and ensure all changes, including security patches, are properly assessed for software compatibility.
  • Stay current with Lab IT trends and technologies, recommending new solutions and improvements.
  • Collaboration & Standardization:
  • Coordinate with regional and global teams to standardize processes and procedures across lab IT systems.
  • Collaborate with cross-functional teams to troubleshoot and resolve automation-related issues promptly.
  • Stakeholder Engagement & Change Management:
  • Manage vendor relationships, ensuring their services meet quality and contractual obligations.
  • Lead stakeholder engagement to manage IT change initiatives effectively and communicate priorities clearly.
  • Strategically influence cross-functional teams and senior leadership to advance Lab IT goals., 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 $117,000.00 - $184,200.00

Requirements

  • Bachelor's degree in engineering, information technology, or a related field.

Preferred Skills & Experience:

  • Minimum of 5+ years of experience in digital systems within a manufacturing environment, with at least 3 years in a leadership/team lead role.
  • Experience supporting digital laboratory systems and applications in a GMP regulated environment (R&D, QC, Analytical, or Development labs).
  • Hands-on experience with Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), and laboratory instrument integration platforms (e.g., Empower, LabWare, LabX, or equivalent)
  • Strong knowledge of digital technologies, systems, and best practices.
  • Deep practical knowledge of COTS laboratory equipment and analytical instrumentation (HPLC, UV, FTIRs, spectrophotometers, titrators, balances, etc.) and their vendor software/applications
  • Familiar with integrating lab instruments and applications with enterprise systems (e.g., LIMS, ELN, data historians, SDC, Scitara, Biovia , MES or reporting platforms).
  • In-depth understanding of the System Development Life Cycle (SDLC) for regulated systems, including requirements, design/configuration, testing, validation, release/change control, and maintenance.
  • Working knowledge of IT/OT standards, cybersecurity, and infrastructure considerations for lab environments (PC-based and non-PC instruments).
  • Excellent problem-solving skills and the ability to think strategically.
  • Strong interpersonal and communication skills, with the ability to influence and collaborate effectively.
  • Demonstrated project management and delivery skills for digital lab initiatives (system implementations, upgrades, instrument integrations, migrations)
  • Proficiency in budget management and financial analysis. Including cost-effective sourcing, standardized onboarding, and spend-tracking of Fixed-Term Contractors (FTCs) for the site.

This role provides a unique opportunity to shape the digital transformation of lab operations at our company, driving innovation and operational excellence.

Required Skills: Audit Management, Budgeting, Business Process Improvements, Cybersecurity, Data Management, Driving Continuous Improvement, GMP Compliance, Laboratory Information Management System (LIMS), Manufacturing Environments, Operational Excellence, Problem Management, Quality Management, Real-Time Programming, Software Development Life Cycle (SDLC), Stakeholder Engagement, Strategic Planning, Systems Development Lifecycle (SDLC), Vendor Management

About the company

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.

Apply for this position