Specialist, Operations

Merck - West Point, PA

Full-time
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.

Position Description

This high impact role in our Company Manufacturing assures that products manufactured comply with cGMPs, operating procedures, and other applicable regulations. The incumbent will:

Support the managers in the direct processing of materials and the associated hourly workforce to ensure attainment of business results.
Effectively collaborate with and manage a work team with specific responsibility for motivating others, ensuring performance, schedule execution, task coordination, equipment and area preparation and effective administration of personnel policies and procedures.
Manage conflict and effect resolution to technical and personnel challenges is key as is openness to change and the ability to effect positive change.
Because our business is dynamic and advances in science and technology require new methods of production we are looking for individuals who can do the following:
Collaborate with team members in the identification and implementation of continuous improvement initiatives and action plans.
Support activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence and lean practices.
Demonstrate integrity, credibility and flexibility in their daily performance so as to motivate others to do the same.
Assure compliance with safety and environmental practices, cGMPs and SOPs in the work area.
Participate in internal audits and inspections.
Initiate the investigation when a quality or safety event occurs during the shift.
Work with members from Quality and Technical Services to properly handle unplanned events.
Ensure that corrective actions are implemented.
Ensure that personnel under are properly trained in cGMPs, procedures, good documentation practices and regulatory matters.
Participate in design and implementation of training and development programs.
Ensure materials receiving and verification in the work area, equipment cleaning, set-up and area cleaning and verification are completed according to procedures.
Assure that materials are properly handled and equipment is properly operated according to SOPs, guidelines, and regulations.
Maintain control of processes and product quality by ensuring compliance with cGMPs, safety and environmental regulations.
Monitor the manufacturing processes during the shift
This position may require occasional weekend work due to the nature of biological processes

Education Minimum Requirement:
B.S. with emphasis in Science, Manufacturing or Engineering

Required Experience and Skills:
Minimum 6 months to 1 year working experience in cGMP or manufacturing environment or equivalent
Willingness to work off-shift or weekends
Computer literacy in MS Office, Word, Outlook, Excel
Ability to identify and implement solutions for continuous improvement initiatives
Willingness to work a minimum of 2 years on 2nd or 3rd shift, potential to rotate coverage to learn processing

Preferred Experience and Skills:
Minimum 2 years cGMP experience in a sterile, bulk, or finished pharmaceutical environment.
Manufacturing plant experience in operational capacity
Experience working within a Union environment
Experience with working in SAP or other Enterprise software
Technical writing experience related to investigations in to mfg process variation

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 that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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.

If you need an accommodation for the application process please email us at staffingaadar@merck.com