Job Description

Job Description

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.

General Summary:

Operations specialist provides support to the manufacturing operations organization. This high impact role in our company will assist in the startup of a new vaccine manufacturing facility and ensure that all products manufactured in this new facility comply with cGMPs, operating procedures and other applicable regulations. The operations specialist focuses on developing and management of the shop floor compliance and implementation of lean manufacturing initiatives aligned with department goals. , the Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Global Engineering Services, Global Technical Operations, West Point Tech Operations, Quality, Automation, our Research & Development Division, and others.

This position will require off shift and weekend work due to the nature of new facility startup and biological processes.

Position Responsibilities:

* Supports the managers in the direct processing of materials to ensure attainment of business results.

* Partner with cross functional team to develop process/procedures.

* Author and update technical and manufacturing documents necessary for facility startup, such as, but no limited to, SOPs, batch records, safety assessments and training plans.

* Author and implement electronic batch record.

* Develop and partake in new facility risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.

* Conduct experimental protocols as needed using production equipment.

* Develop and support digital and data integrity tools.

* Develop and assure consistent application of standardized work, engineering, and process tools

* Develops an in-depth knowledge of the equipment and process.

* Builds knowledge of the company, process, clients and/or customers.

* Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group.

* Manage conflict and effect resolution of technical and personal challenges using standard procedures is key as is openness to change and the ability to effect positive change.

* Contributes and adds value to the achievement of team goal.

* Inventory and process order management in SAP and PAS-X.

Compliance:

* Responsible for the on-time completion of the process within the bounds of the SOPs and batch record.

* Working with the Deviation management and quality departments to trouble shoot the process.

* Ensure compliance with safety and environmental practices, cGMPs and Standard Operating Procedures in the work area.

* Demonstrate integrity, credibility, and flexibility in their daily performance so as to motivate others to do the same.

Business Expertise:

* Perform a thorough review of batch records and related GMP documentation, identifying and resolving discrepancies in a timely manner and implementing corrective actions to improve the batch record execution/review process.

* Work with subject matter experts provide/track necessary training for operator qualification as assigned.

* Participate in the design and implementation of training and development programs and training materials.

* Foster a collaborative relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions and reducing the deviation generation rate.

* Determines/implements appropriate and effective corrective and/or preventative actions to prevent reoccurrence of deviations and ensure they improve the Right First Time metrics.

Problem Solving:

* Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using standard procedures.

Decision Making:

* Makes decisions that are guided by site policies and procedures.

* Collaborates with supporting departments such as Quality, Tech Ops and Maintenance to solve problems in an efficient and compliant manner.

* Consults with manager on more complex decisions and issues that impact other departments.

Project Management:

* Accountable for contribution to project team or sub-team, may manage/lead a small project team.

* Collaborates with team members in the identification and implementation of continuous improvement initiatives and action plans.

* Supports activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence, and lean practices.

Resource Management:

* Aware of costs and assists in controlling costs related to own work.

Education Minimum Requirement:

* Bachelors Degree in Biology, Biochemistry, Chemistry, Engineering or relevant discipline.

Required Experience and Skills:

* Familiarity with cGMPs in pharmaceutical/biotech industry.

* Demonstrates strong problem-solving skills and a hands on approach to problem solving.

* Ability to work independently.

* Willingness to work off-shift and weekends.

Preferred Experience and Skills

* 1-2 years cGMP experience in a sterile, bulk or finished pharmaceutical/biotech environment.

* Experience with formal problem-solving techniques, such as root cause analysis (RCA), failure mode effects analysis and/or Lean Six Sigma Tools.

* Manufacturing plant experience in operational capacity.

* Experience working in a Union environment.

* Experience working in SAP and other Enterprise Software.

* Knowledge of Code of Federal Regulations.

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

Who we are

We are known as Merck & Co., Inc., Kenilworth, 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

3
Requisition ID:R105121