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Job Details


Merck & Co. Inc.

Associate Director, Pharmaceutical Technical Operations

Pharmaceuticals

All

Yearly

No

Wilson, North Carolina, United States

Job Description

Our Engineers support 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.

Job Description:

Responsible for providing technical support in determining best method for providing optimum performance in manning, equipment, systems, documentation, and asset utilization. This role is also responsible for process performance support and troubleshooting products manufactured/packaged at our Company Manufacturing Division (MD) at our Wilson location and working closely with other site and above- site groups for the introduction of new products, network transfers and processes.

Primary Responsibilities

  • Provide engineering support for the new and in-line pharmaceutical product to Manufacturing operation

  • Responsible for the scale-up and technology transfer of pilot processes to production scale for MD-Wilson, which includes support for equipment design, equipment qualification, process demonstration, and process validation

  • Provides technical assistance to packaging operations in the resolution of processing problems for in-line products

  • Provides written scientific justification for proposed changes by conducting literature search, designing and executing experiments, analytically reviewing current and past data, and demonstrating the impact of changes on product quality, production efficiency, or productivity

  • Provides technical assistance for quality and regulatory activities including site inspections, preparation of technical documents for NDA supplements, FDA observations, and environmental process issues

  • Ensure processing/packaging operations consistently meet all quality requirements, which requires a thorough knowledge of operations, critical quality attributes, the risks involved, and the in-process controls necessary to obtain reproducible results

  • Responsible for completing all packaging and engineering/process development activities with the highest regard for all company divisional policies and Wilson site procedure for safety, quality, and regulatory compliance

  • Review literature pertaining to pharmaceutical packaging and manufacturing in order to introduce new profitable/productivity ideas into the manufacturing operation

  • Provides technical support in critical quality standard specifications and methods for raw materials and intermediate and final products

  • Recruits, selects, and develop high caliber engineering and scientific personnel to meet our Company objectives, while adhering to all employment activity policy

  • Actively promotes the scientific and professional growth of PTO through mentorship, training, and specific project opportunities

Education Minimum Requirements

  • Bachelor's degree in engineering or equivalent and a minimum ten years of experience in formulation development, pharmaceutical unit operations, or process design.....OR a Master's degree in engineering or equivalent and a minimum eight years of experience.....OR a Ph.D. and a minimum three years of experience.

Required Experience and Skills

  • Comprehensive background in pharmaceutical and packaging

  • Experience working in GMP environment

  • Prior experience in supervisory/management capacity

  • Demonstrated leadership and teamwork skills

  • Effective analytical and decision-making ability

  • Effective written and verbal communication ability

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 …

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 …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with [Register to View] 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.

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Current Contingent Workers apply [Register to View]

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please [Register to View] if you need an accommodation during the application or hiring process.

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

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Domestic

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R131910