Senior Specialist, Engineering

Job Description

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

WHAT YOU WILL DO

As a Process Engineer you will provide process engineering support for Manufacturing Operations to drive continuous improvement in safety, quality, process efficiency and compliance in cGMP manufacturing facilities. Expected to support various site Initiatives and action plans leveraging Quality, Safety, Enterprise, Technology and Project platforms, Engineering Standards, Codes, and support department business goals and objectives.

MAIN RESPONSIBILITIES:

Process Engineering:

• Provide Process Engineering Support for API manufacturing plants in support of business continuity & continuous improvement to meet Safety, Quality, Environmental, Regulatory and Compliance Objectives.

• Support Deviation Management related to the Process Equipment, Manufacturing Support Systems in response to deviations/ adverse events to investigate and implement corrective and preventative measures.

• Support Global Change Management under various our Enterprise Platforms to ensure the Equipment, Facility and Process system changes are executed complying to site procedures and SN MOC standards.

• Provides technical expertise for compliance activities such as audit and regulatory support. Acts as primary regulatory representative with business partners and regulatory agencies for moderately complex systems, programs, or issues.

• Where applicable, develop or update SOPs, perform procedural gap analysis for Quality/EHS subsystems/ topics to comply with regulatory, divisional policies, and guidelines. Typically possesses advanced and/or expert knowledge in at least one compliance topic. Conduct trainings to the impacted groups.

• Demonstrates and promotes Environmental, Health & Safety (EHS) leadership behaviors, ensuring that all activities are conducted in accordance with EHS procedures. Leads/ participates Process Hazards Analysis (PHA), LOPA engineering studies and applicable Process Safety Management (PSM) activities related to new/inline products. Support EHS audits and PSM incident investigations.

Project Management:

• Lead minor Portfolio Projects to introduce new technology, site tech transfers, implement new requirements from Engineering Standards, Codes and Practices to drive Process Safety, Quality Compliance, Process & Energy efficiency. Follow the implementation through feasibility, Initiation, Business case, Design, Sourcing, Detail Design, Installation, Commissioning, Qualification (IQ, OQ) and handover. Ensure adherence of project activities to site change control process to ensure facilities are safe, efficiently utilized, reliable and meet GMP/ regulatory / production requirements within the scheduled timeline, budget, design requirements, and established quality standards.

• Demonstrate good project management skills (e.g., define core team and activities, project scheduling, stakeholder management, define A3 Project charters etc.) to lead site Hoshin portfolios or major impact work streams. Coordinate with GES, GSE or Global Functional group SMEs in implementation of projects.

Functional Competency:

• Provide SME expertise as Engineering Representative for various Site Capital projects to support design reviews, feasibility assessments and actively collaborates for sharing of best practices. Oversee assigned site Capital projects as Engineering Services stakeholder to drive design standardization and optimization of practices and requirements.

• Provide SME expertise for engineering aspects to support MOM MHD safety case responses, gap assessments and implementation.  Support onsite audit representation for design topics & sustain phase change management.

• Conduct Process Safety Gap assessments for the current facilities, process systems & installations vs updated GES engineering standards, SN standards or updated requirements to propose optimized remediation plans.

Other requirements:

• Demonstrates leadership behaviors and leads personal career development with manager assistance through Performance Management and Employee Development Plans.

• Mentor and coach junior engineers on enterprise platforms, their application, to support their co-learning, OJT learning plans and knowledge management.

• Exhibit analytical skills, analyze data & frame right questions, and propose solution options.

• Consistently display critical thinking and able to develop plan, system or procedures that are not well developed.

• Should be able to influence people & make decisions at right level.

• Any other duties as assigned by the Supervisor.

WHAT YOU MUST HAVE

• Bachelor’s degree in chemical or chemical Process Engineering.

• Minimum 7- 12 years technical experience in pharmaceutical manufacturing industry

• Possess data analysis and critical thinking skills, knowledge of GMP systems, equipment design, equipment qualification and Operational & Maintenance requirements.

• Apply Systematic problem-solving methods with MPS orientation & belt certified.

• Highly collaborative ways of working with inclusive behaviors and effective communications to influence and deliver the commitments.

• PSM knowledge to support incident Investigations, PHA, LOPA studies & PRD assessments.

• Process engineering experience to conduct feasibility studies, develop and implement feasible technical solutions.

• Project management skills, planning, costing, scheduling and work with multi-functional teams.

• Experience in petrochemical background, working in areas such as plant operations, process engineering, research and development, maintenance, or technical support within a petrochemical facility or related industry.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact 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):

Requisition ID:R268814