Job Description

A fantastic opportunity has arisen for an Associate Director, Digital Shop Floor Lead.

This role will be the face of Digital Manufacturing Operations (DMO) to the Engineering  and will be accountable for all aspects of technology supporting the IPTs in their primary mission of compliant production of our products.

Bring energy, knowledge, innovation to carry out the following:

Work closely with the site Engineering function to understand current and future end-user needs for facility & utility systems.Partner with Product teams to ensure technical solution development is incorporated into future architecture designDrive the standards for deployment of new technology at the site, in line with the site 5-year plans /roadmaps.Leadership activities including selection, development, coaching and day to day management of ta team of staff and contract resources.Ensure systems meet all necessary computer security, GMP, validation and business continuity planning requirements and maintained in compliance with the global and site quality system.Drive continuous improvement by leading and participating in system failure investigations, RCAs, execution/development of change control and implement subsequent corrective actions.Work closely with the global product teams to execute a strategy to optimize systems & digital operations, and maintain a roadmap for the site in partnership with the value team.Manage the support maintenance and contractual relations for key plant systems including Contractor and Vendor Management, Consultants and Outsourced Service Providers.Coordinate IT system lifecycle to manage compliance and cyber security risks to ensure they are proactively managed.  Ensure implementation of new systems meeting a defined set of infrastructure and architecture required to support the business. Represent Digital Manufacturing Organisation in site governance meetings, at global technical forums and global IT Tiers.Drive effective writing/revising/ rolling out of accurate operational procedures, training documents and procedures for various IT Automation systems.Work collaboratively to drive a safe, compliant and inclusive culture at site.

What skills you will need:

In order to excel in this role, you will more than likely have:

Degree qualification (Science/Computer Science/Engineering/Technical)10+ years’ experience in automation systems in a regulated manufacturing environmentStrong understanding of IT & Automation systems that support pharmaceutical manufacture (DCS, PLC Systems, Pi, MES, LIMS etc), management and data capture systems and other analytics-based systems.Effective communication skills to interface effectively with all levels of colleagues in a team environment, and with vendors, contractors, and customers.Strong Project management and financial acumenKnowledge of global health regulatory requirements and requirements that drive digital delivery, including 21-CFR-Part-11, Annex 11, Good Laboratory and Manufacturing practices, Computer Systems Validation, and other global regulatory requirements that impact computerised systems.Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.Ability to lead others to solve complex problems and identify innovative solutions.Ability to work with all levels of business customers in a dynamic environment.Interpret business challenges and best practises for improvements to systems and processes.Experience of Biotechnology and Vaccines manufacturing processes preferred.Ability to partner and communicate effectively with all levels of the organization with strong decision-making capability.

As a company, we are committed to 'Inventing for Life' in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, please apply today.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/6/2025

*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:R328002