Job Description

An opportunity has arisen for a Bio-Process Associate - Drug Product.

The role will be in a green field site manufacturing a life changing medicine utilising the latest fill/finish technology.

You will be part of a multiskilled team lead by a shift leader. Please note this is a shift based role operating a 4 cycle 24/7 shift pattern.

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

Perform all core production activities in DP facility.   Manufacturing processes include  and Drug Product Filling, Capping and Inspection Preparation of equipment for use in the manufacturing process    Support the development, commissioning & qualification of a new vaccines manufacturing equipment.Assist in maintaining a safety orientated Culture, cGMP compliant work environment. Responsible for completion of manufacturing tasks according to SOPs and batch records (paper and electronic).  Perform initial troubleshooting of issues identified during routine operations.  Assist with the investigation of manufacturing deviations through Quality Systems, engaging with all relevant personnel and functions as appropriate.  Write, review, revise and approve of area SOPs, Batch Records, Logbooks, Training Competencies and Work Instructions  Training and mentoring of colleagues in SOPs, process execution and equipment operation.  Seek opportunities for Continuous Improvement using Lean/Six Sigma tools as part of daily operations (Standard Work, TPM, 5S).  Where necessary assist in any in Facility and Equipment start up and Validation activities.   Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations.  Capable of collaborating with individuals and with a team of up to 20 people  Provide technical leadership by acting as ‘Champion’ to drive improvements and excellence within specific aspects of the manufacturing operation within the shift team e.g. Environmental Monitoring, Lean. Provide manufacturing status update during shift handovers.  Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training.  Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.  Conduct all activities that are in accordance with Company policies & SOPs  & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate. 

What skills you will need:

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

Certificate, Diploma, Degree, Trade qualification or equivalent demonstrated experience of 12 months or more experience in a regulated environment, GMP environment.Experience in biopharmaceutical industry is an advantage.Involvement working in a fast-paced green field project would be an advantage.  Experience with recording information in real time using electronic or manual systems.   Experience in executing operations while following SOPs, Batch Records and Manufacturing Controls Systems. Experience of working in Grade B, C, D and CNC environment is an advantage.  Excellent interpersonal skills, positive influence, team orientation, attention to detail, documentation skills, problem identification and problem-solving skills.  An ability to work independently, and as a member of a self - managed shift team in a dynamic, fast-paced environment that requires flexibility and initiative. 

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):

Required Skills:

Biopharmaceutical Industry, Biopharmaceutical Industry, Biopharmaceutical Manufacturing, Biopharmaceuticals, Biopharmaceutics, CNC Operations, Computer Literacy, Data Analysis, Equipment Maintenance, FDA Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Laboratory Techniques, Maintenance Processes, Manufacturing Processes, Manufacturing Quality Control, Master Batch Records, Material Selection, Pharmaceutical Process Development, Process Management, Process Manufacturing, Production Planning, Regulatory Compliance, Shift Work, Six Sigma {+ 4 more}

 Preferred Skills:

Job Posting End Date:

*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:R351180