An exciting opportunity has arisen for a Manufacturing Science &Technology, Validation Specialist. This position will be part of the MS&T Hub at the State-of-the Art, Single-use, Multiproduct Biotech facility at Dunboyne Biologics. You will play a key role in the delivery of an innovative biologics pipeline for patients.

What we look for:

This role requires an experienced and enthusiastic individual who is comfortable working independently and on multidisciplinary teams. The successful candidate will have demonstrated the ability to deliver excellence on accelerated timelines, with strong technical and interpersonal skills and an ability to hold oneself and the team accountable for commitments, decisions, actions and behaviours. We are excited to form a highly inclusive, passionate, and powerful validation team and look forward to your application!

What you will do:

Reporting through the validation lead, the Specialist will support process, cleaning, and sterilization validation to enable the introduction of new clinical and commercial biologics. Responsibilities include, but are not limited to the following:

• Supporting the execution of the site Validation Master Plan.
• Supporting the completion of cleaning and sterilization cycle validation activities and supporting at least 2 process validations.
• Trending KPIs and for continuous process verification and improvements.
• Drafting Process Performance Qualification (PPQ) protocols and reports.
• Maintaining the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.
• Authoring and reviewing standard operating procedures and technical reports.
• Supporting global regulatory submissions as needed.
• Applying LeanSixSigma in the Validation group by:
  • Securing continuity of an appropriate LSS/CEM level of knowledge.
  • Facilitate problem solving & risk assessment (FMEA) projects/meetings.
  • Making problems visible and strive for continuous improvement.

• Lead and support various organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

What skills you will need:

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

• A bachelor’s Level 8 degree in a technical field (e.g. Engineering, Science or equivalent), with > 2 years’ experience in the biotechnology ideally in validation.
• Technical knowledge in biological drug substance upstream and/or downstream equipment is desirable, and working knowledge of Manufacturing Execution Systems / Automation
• Process, Cleaning and Sterilization Validation knowledge is desirable.
• Flexible and efficient, with a proven ability to collaborate cross-functionally.
• Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software)
• Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes

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.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So, if you are ready to:

Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, 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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R187236