Job Description

A fantastic opportunity has arisen for a Senior Operations Specialist 

You will be accountable for end-to end production supporting production (Cell Expansion,  Fermentation, Purification, Solution Supply) for both Batch and Continuous Manufacturing. 

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

Operate equipment according to electronic batch records, sampling plans and standard operating procedures. Responsible for monitoring operational performance, follow-up on any significant adverse trends for the identification and implementation of operational optimization, and robustness improvement projects. Work with Facility Management / internal team members in the maintaining of GMP status of responsible equipment devices in routine monitoring, calibration, maintenance, and certifications. Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.  A Change and QRA Champion within the organization and site, to bring about new technologies, digitization, and identify opportunities to bring new ways of working. Support weekend or on-call duty on select time frames to support manufacturing. Use the extensive operational experience to mentor new members of staff in specific plant activities when required and as a key point of contact for external groups to  Conduct work activities in a safe and compliant manner. Support the Authoring of electronic batch records, sampling plans, and standard operating procedures. 

What skills you will need:

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

Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering. 8 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components).  Position level will scale with experience level of candidate. Competent in analyzing complex situations and show practical problem-solving capabilities. Ability to work independently and within a cross-functional team. Understanding of multi column chromatography concepts Familiarity with contamination control and batch release requirements Problem, Deviation, and Change Management experience  Understanding of Upstream and Downstream Unit Operations for mAb manufacturing Proficiency in with Emerson DeltaV, SIPAT,  and the use of Automation in a manufacturing Process. Proficiency in various SingleUse techniques and experiences in the area of an end to end Single Use facility.

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

03/1/2025

*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:R334017