Assoc. Spclst, Operations (WDA)

Job Description

Operations Support Specialist

Reporting to the Operations Senior Manager you will be responsible for coordinating and supporting all manufacturing related activities for the Integrated Process Team (IPT).

In this role, you will:

• Assist the Production Leaders in the allocation of resources, training of technical skills and prioritize any other shop floor ad-hoc activities.

• Complete post-packaging batch documentation review and lead initiatives to improve straight-through documentation, including serialization.

• Act as the IPT SAP Super-User and serialization SME.

• Prepare and issue necessary documents for production use and lead the change executions for manufacturing documentation when needed.

• Support development of a continuous improvement framework within the overall IPT improvement program.

• Support model area implementation on continuous improvement on workflow within packaging IPT

• Process of POs and manage inventory for consumables, PPE, gowning, tools and equipment to support IPT operations.

Key Responsibilities:

     Operation

• Perform manufacturing batch review within MBTR target

• Coordinate technical skills training for shopfloor staff during hands-on training as required

• Overall manage the Manufacturing Aids (MA) classification and buying process to commercial batches.

• Process of POs and manage the inventory for non-Bill of Materials, consumables, tools, PPE, gowning, and equipment to support qualification phase and commercial batches.

• Any other adhoc duties assigned by Supervisor

    Safety & Compliance

• Ensure that all assigned daily manufacturing activities are planned and carried out in accordance to Environment, Health and Safety (EHS) requirements.

• Participate in and support the implementation of actions for all incident’s investigations and audits as required.

• Ensure all regulatory permit requirements are met for IPT maintenance activities.

• Promote EHS leadership behaviors and engage employees at all levels on EHS issues.

• Support to meet Profit Plan and cost effectiveness targets.

     Enhance and uphold Operations Quality

• Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.

• Prepare or update procedures and related documents to ensure compliance with regulatory standards.

• Actively engage in audits and support implementation of agreed follow-up actions.

     Operations Excellence

• Prepare and issue necessary documents for production use. These documents are the batch records, manufacturing labels and other essential documentation related for production such as SOPs and Work Instructions (WI).

• Lead the change executions for manufacturing documentation in liaise with other departments in Pharm such as PTO/Process Engineering, Quality and Manufacturing. This includes emergency changes related to the batch documentation when needed.

• Support document revision (SOP, WI, Forms, etc.) when necessary to improve the system of documentation review, issuance, and preparation.

• Maintain proper filing and safe keeping of all relevant manufacturing documents; and retrieve them when required.

• Complete manufacturing batch record review in accordance with cGMP requirements.

• Coordinate SAP shutdown maintenance, support all SAP and MES inventory updates and reversals

Continuous Improvements (CI)

• Utilize MPS tools (8-steps Problem Solving, SMED, 5S, etc) to support execution of continuous improvement projects to increase agility, flow, throughput and reduce cycle time and inventory.

• Support implementation of model area

• Initiate Continuous Improvement (CI) activities in area of responsibility – Batch document simplification, SOP & WI process review, etc.

• Collect date for APQR, Profit planning and management of Tier process.

What are we looking for?

Qualifications & Experience

• Degree or diploma holder in Science, Engineering, or related studies.

• At least 2 years of experience in manufacturing, operations, logistics, or technical support environments.

• Good knowledge of applicable Safety and GMP regulations would be an added advantage.

Professional Competencies

• Strong work ethics

• Result-driven mindset

• Continuous learning mindset

• Foster cross team collaboration

• Resilient and resourceful

• Effective communication skills

• Conflict Management

This is a career conversion program under Workforce Singapore (WSG) and candidates must meet the following criteria and are open to the following conditions:

• Singaporeans/Singapore PRs only

• PMETs/Mid-Careerist with no prior work experience in Biopharma industry are welcomed to apply

• Open to two years contract

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Manufacturing; well-structured career path 

• 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.

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. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Required Skills:

Preferred Skills:

Current Employees applyHERE

Current Contingent Workers applyHERE

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):

Job Posting End Date:

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