Senior Specialist Upstream Operations Support

Job Description

A fantastic and exciting opportunity has arisen for an Upstream Operations Support Senior Specialist.

The role will provide key operational support to the Upstream shift teams to ensure right first-time execution/delivery of production batches and timely closure of Batch Record Reviews. The successful candidate will support routine operations in the areas of safety and GMP compliance. Reporting into the Upstream Operations Support Manager this role is key to supporting upstream manufacturing activities through a combination of on the floor hands-on work and technical support and backup.

This position will play a pivotal and critical role in the manufacture of biologics-based medicines, including immuno-oncology.

The role requires good organisational skills, excellent troubleshooting capability and a strong sense of accountability to ensure Upstream Operations meet strategic targets.

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

• Act as a core member of the Upstream Integrated Process Team (IPT) ensuring safety, quality and delivery metrics are maintained at all times.
• Collaborate with cross functional teams providing expertise in support and technical areas as required by the Shift Teams.
• Build and maintain effective relationships within IPT stakeholders ensuring effective communication from days to shift teams.
• Utilise problem solving tools and Continuous Improvement techniques to deliver safety and process improvements.
• Work collaboratively with the technical operations team, shift operations and other IPT support functions to deliver site production requirements.
• Participate and lead projects, cadence initiatives and cost saving efforts.
• Provide process and operational expertise within the IPT, in areas such as the introduction of new equipment and processes.
• Act as point of contact between the operations and supply chain team on issues working collaboratively to successfully deliver effective material management/processes.
• Collaborate with IPT Stakeholders to implement best practices and continuous improvements for operations activities.
• Identify and take ownership of changes to Upstream Bill of Materials (BOM).
• Support permanent inspection readiness (PIR) activities within the operations team, ensuring a state of PIR is maintained.
• Ensure effective/on-time completion of Standard Operating Procedures/Work Instructions (SOP/WIs), provide updates as required and remove obstacles impacting delivery of same.
• Ownership and on time completion of Quality investigations and CAPAs.
• Support Changeover Readiness and future product introduction.

What skills you will need:

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

• A Degree in Science, Engineering, or other relevant disciplines.
• 5 years experience in the Pharmaceutical industry.
• Start-up experience in a large-scale commercial drug substance facility highly desirable.
• Experiences across multiple site functions including but not limited to Quality, MSAT, Engineering, or Supply Chain.
• Proven experience in Continuous Professional Development.
• Experience leading and delivering projects and improvement initiatives.
• Ability to interact with multiple stakeholders across numerous departments utilising effective communication skills.
• Strong MS Office skills e.g. Excel, PowerPoint to generate metrics, presentations.
• Good Working Knowledge of COMET SAP, MES PASX and Batch Record Review Process.
• Knowledge of and experience in applying MPS/Lean Six Sigma methodologies, with an understanding of regulatory and validation requirements.
• Knowledge of MS Power Apps, Power BI and Generative AI is desirable.

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.

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/4/2025

*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:R341183