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Merck Specialist, Engineering in West Point, Pennsylvania

Job Description

Our Engineers help ensure that 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.

The External Manufacturing Technology organization is seeking a highly motivated individual for a Specialist Engineering position. This individual will support a wide range of activities including commercial production of sterile drug product at our Company External Partners and / or technical transfers of sterile drug product to and from EPs.

Primary Responsibilities:

  • Reports to Associate Director or Director, External Manufacturing Sterile Technology, and receives general direction on goals and objectives. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues.

  • Supports technical transfers as applicable through authorship or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.).

  • Provide on-site coverage at external partner in support of Development Batch Coverage, Process Performance Qualification Coverage, or Person In Plant Activities.

  • Supports commercial production as applicable through technical review of atypicals, authorship of change control, management of process improvement projects, and statistical analysis of process performance.

  • Partners with External Partners to achieve business goals and to establish a common culture that benefits both our company and External Partners.

  • Understands the GMP requirements and current regulations and partners with Operations, Quality, and External Partners to develop more efficient ways to meet these requirements.

  • In concert with Operations, Quality, and Regulatory, ensures that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers.

Education Minimum Requirement:

  • Bachelors in chemical/biochemical engineering, pharmaceutical science, or chemistry/biology, or other related field.

Required Experience and Skills:

  • Minimum two (2) years' post-bachelor's degree experience or 1 years' experience with a Masters degree in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.

  • Developed communication, leadership, and teamwork skills.

  • Ability to manage projects/work to schedule/deadlines.

  • Travel will be a requirement of this position at approximately 25%.

  • Must be able to multi-task and work within tight deadlines.

  • This position requires flexibility and the ability to work independently, as well as excellent organizational skills.

  • Strong professional and interpersonal communication skills are also required.

Preferred Experience and Skills:

  • Experience in sterile / aseptic manufacturing.

  • Experience in deviation management and/or change control and/or equipment support, and/or project management.

  • Basic statistics experience.

Our Manufacturing & Supply Division is committed to being the most trusted supplier of biopharmaceuticals 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

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster at https://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf

EEOC GINA Supplement​ at https://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

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:

Travel Requirements:

25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

2

Requisition ID: R45661

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