Assoc Tech

Job Description

Associate Technician, Operations (2 years contract)

THE OPPORTUNITY

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.

WHAT YOU WILL DO

As a technician, you will join one of the teams who manufacture our medicines. The environment that these teams work in is a clean room environment doing filling of sterile vials. Each team is approximately 10 people working on a 24x7 shift pattern. We are proud of being a diverse organisation with an even split of genders at a technician level within Biotech.

Expectations

Achieve competency in the following as Associate Technician (O1):

Qualified in at least 1 of 4 Operating Modules

• Parts Prep/ Autoclave
• Formulation
• Filling
• AVIM/ Inspection

Proficient in 1 of 3 systems (Perform independently)

• MES
• SAP
• GLIMS

Proficient in all support activities (Perform independently)

• Cleaning & Sanitization
• EM Sampling
• Material Management

Apply MPS

• Standardized Work
• Problem Solving/ On-Point Problem Solving

Routine Operation

• Setup and operate pharmaceutical production equipment including high-speed filling lines for sterile injectables, robotic technology, compounding panels and automatic CIP/SIP.
• Dispense, formulate and fill active biological product batches as required to meet the production schedule.
• Perform routine QC sampling and in-process testing of the product at various stages throughout manufacturing i.e bioburden sampling, water sampling.
• Microbial sampling and swabbing of room and equipment.
• Perform cleaning and upkeep of the Grade C & D cleanrooms and production equipment.
• Perform filter integrity testing using an automatic filter integrity test unit.
• Preparation of equipment including loading and starting of sterilisation cycles in autoclaves.
• Complete batch documentation as required including raising of exceptions in a DI compliant manner.
• Perform in-process sampling on semi-finished drug products.
• Perform visual inspection, labeling and packaging on semi-finished drug products.
• Perform all tasks in accordance with the standard operating procedures and maintain strict compliance to GMP at all times.

Event, Atypical Investigations

• Report QN/deviations if any.
• Participate in SHE, Business Compliance, cGMP and compliance matters, where applicable.
• Responsible to escalate Operations issues to Lead Tech or Shift Manager when required.

Continuous Improvement

• Responsible to participant in Kaizen events in pharm operations in accordance with Kaizen plans when assigned.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• A Diploma or Technical School graduate with background in operations and maintenance or any relevant studies
• Must be willing to work in 24x7 rotating shift pattern.
• Min 2 -8 years of working experience preferably in manufacturing industry preferred depending on the level of the role you are applying for (O1 to O3).
• Good understanding of safety procedures/practices.
• Good command of English to be able to read and understand procedures, write simple comments, and communicate with team.
• Ability to work collaboratively in a team environment.

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Pharmaceutical Manufacturing.
• A state-of-the-art facility that delivers solution to its customers world-wide
• Highly engaging team that aims to innovate the future.
  

Our Manufacturing & Supply Division is committed to be the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Current Employees apply

Current Contingent Workers apply

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.

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Relocation:

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