Specialist - Operations

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

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 linked to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

This high impact role in our Company Manufacturing assures that products manufactured comply with cGMPs (current good manufacturing practices), operating procedures, and other applicable regulations.

Position Tasks:

• promote leadership in managing the manufacturing process and the associated hourly workforce to ensure attainment of business results.
• Effectively partner with a work team with specific responsibilityfor motivating others, ensuring performance, schedule execution, task coordination, equipment and area preparation and effective administration of personnel policies and procedures.
• Ability to manage conflict and effective resolution to technical and personnel opportunities is key; as is openness to change and the ability to influence positive change.
• This high impact role in our Company Manufacturing assures that products manufactured comply with cGMPs, operating procedures, and other applicable regulations
• You will be expected to remain in this role for a minimum of two (2) years.  Promotion into an Operations Manager role is not guaranteed, and is dependent on the incumbent's execution of the tasks and expectations of the role.
• Because our business is dynamic and advances in science and technology require new methods of production we are looking for colleagues who can do the following: 
• Partner with team members in the identification and implementation of continuous improvement initiatives and action plans.

• Promote 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.
• 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 are properly trained in cGMPs, procedures, good documentation practices and regulatory matters.
• Participate in design and implementation of training and development programs.
• Ensure 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
• Review Batch Records and effectively partner to ensure prompt and successful resolution of issues
• Develop, Update and Modify SOP’s as needed

This position may require occasional holiday, weekend and off-shift work due to the nature of biological processes

Education Minimum Requirement:

• BS with emphasis in Science, Manufacturing or Engineering preferred

Required Experience and Skills:

• Minimum one year working in cGMP or manufacturing environment
• 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 two years in this role

Preferred Experience and Skills:

• Minimum two years cGMP experience in a sterile, bulk, or finished pharmaceutical environment.
• Manufacturing plant background in operational capacity
• Experience working  within a Union environment
• Knowledge with working in SAP or other Enterprise software
• Technical writing experience related to investigations in to mfg process variation

Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an codependent global manufacturing network that’s interlinking 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.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R78296