Specialist, Laboratory Operations Equipment Support

Job Description

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 Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Specialist, Laboratory Operations Equipment Support is responsible for managing and supporting activities necessary to track, administer, and approve equipment, standard, and instrument Preventative Maintenance (PM) and calibration for systems utilized within assigned areas of Laboratory Operations. The incumbent assures operation in accordance with Manufacturing Division (MD) and Company safety policies, procedures and cGMP regulations, and helps assure that operation costs remain within departmental budgets.

Primary Activities

• Conduct equipment qualification from approved qualification protocol
• Conduct equipment decommissioning as assigned
• Updating calibration and equipment databases as necessary
• Writing and circulating SDLC documentation
• Provide assistance to Deviation Management with investigations as necessary
• Support Corrective and Preventative actions to support re-occurrence of atypical events
• Support management of portable equipment, and help manage calibration circulation of laboratory pipettes
• Provide support to Regulatory Agency inspections as needed and Actively participate in the Tier process and use this forum to escalate concerns and best practices
• Assist Senior Equipment Support Specialist as necessary
• Assisting with operational improvements, conducting instrument qualification, assisting with system decommissioning, assisting with and/or authoring Periodic Monitoring Reviews, assisting with portable equipment management, and helping to support run the business activities conducted within Lead Optimization (LO)

Education Minimum Requirements

• Bachelor degree or higher in life science, scientific discipline or engineering preferred

Required Experience and Skills

• A minimum of two (2) years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operation, Technical, or Regulatory function supporting manufacturing or testing operations, or related industry experience in laboratory, manufacturing, science related or regulated field

Preferred Experience and Skills

• Basic familiarity in supporting deviation reports and/or other regulatory reports
• Technical expertise in laboratory testing
• Proven analytical aptitude, critical thinking skills and ability to apply key concepts
• Speaks with courage and candor
• Effective written and verbal communication skills
• Proven ability to manage multiple project simultaneously
• Pharmaceutical laboratory operation or related environment
• Demonstrated experience of Primary Job Activities

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted 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 [email protected]
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:R71123