Job Description

This position plays a key role in sustaining our primary areas of focus, that are of greatest relevance to our business and society; access to heath, employees, environmental sustainability, and ethics and values.

-Upholds safety and quality excellence when making operational decisions that optimize supply chain and financial targets.

-Supports and provide guidance to shift personnel to deliver excellent operational results in a highly regulated, fast-paced API production facility.

-Assist the Senior Manager, Operations in all aspects of production activities and technical support in all aspects of equipment / facilities.

Manufacturing Excellence

Supply & Cost

-Supports the plan, schedule and coordination of maintenance activities with maintenance team and IPT planner with support from other engineers and Senior Manager. Supports activities that interfere with production in order to reduce downtime.

-Supports all permits in the operations areas. Supports to ensure that all work is successfully completed.

-Serve as landlord for facility with support from other engineers and Senior Manager. Works with operations staff and maintenance team to correct deficiencies in housekeeping, maintenance, and facility related procedures.

- Manage materials and supplies storage and logistics within facility.

- Generates/support qualification and functional verification document for commissioning.

- Participates/supports equipment commissioning, including FAT / SAT.

- Generates/supports plant modification proposals and track changes to completion.

- Generates/supports generation of cleaning batch sheets for product change-over and new equipment.

- Participate in cleaning development and cleaning validation activities

- Will support PTO in technology transfers for new product introductions into the plant.

- Manage the operations supply system, including coordination with planner/buyer and maintenance team, to ensure that material and supply inventories are maintained at appropriate inventory levels.

- Work closely with planner/buyer for sourcing and purchasing of plant consumables and accessories.

- Manage manufacturing aids, inclusive of supporting and generating necessary documentation

Training

- Carry out training on new operations SOPs and on-the-job training for technicians, including cGMP, SOPs and safety procedures as needed.

- Works closely with the learning specialist to develop the training packages including the competency based framework for any new or revised SOP.

Quality / SHE Stewardship

Quality Compliance

- Participate in Proactive Process Analysis (PPA).

- Demonstrates ability to lead/support investigations associated with equipment, facilities, and people with support from other engineers and Senior Manager

- Conduct periodic review of equipment qualification, SOPs, preventive maintenance activities and calibrations.

- Able to support internal, external and corporate QA audits and follow-up on corrective actions and preventive actions.

Generate SOP’s for plant operation in accordance with cGMP and conduct training.

- Able to write technical documents for investigations and audit responses.

Safety

- Demonstrates and promotes a safe and injury free work culture and engages employees at all levels on SHE issues.

- Participate in HAZOP Studies, FMEA, RCFA, Industrial Hygiene related activities

- Participate in internal, external and Corporate Safety and Environmental audits and follow-up on corrective actions and Preventive actions.

People Excellence

- Serve as point of contact in all aspect of production activities and technical support of all production equipment and facilities.

- Participate in MPS related activities to instill continuous improvement mindset in the operation team.

- Leads personal career development with manager assistance through annual performance management, employee development plan and career mapping

- Carry out specific administrative tasks as instructed by the Senior Manager, Operations.

- Any other duties as and when assigned by the Manager.

Qualification:

- Bachelor’s Degree in Science, Engineering or Diploma in Chemical Process Technology

Experience:

-Pharmaceutical experienced preferred, fresh graduates are encouraged to apply

- Experience with continuous improvement, Lean Six Sigma methodology and

the application of Lean tools (preferred)

- For non-Diploma holders, minimum 3 years of experience.

Leadership, Professional and Functional Competencies*

- Refer to Career Framework Competency Model

Other Personal Attributes*:

- Leadership qualities and team player

- Ability to multitask

- Reliability, responsibility, and personal integrity

Required Skills:

Preferred Skills:

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):

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.