Specialist, Engineering Validation

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.

We are seeking individuals with strong scientific and technical skills to contribute to the design, development and manufacturing of sterile products, making accessible our company's next generation of Vaccines and Biologics. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We have an exciting opportunity for a Specialist, Engineering to join the technical operations Team supporting a capital project critical to Human Health at our facilities in Durham, North Carolina. This new facility will include end-to-end processing of both drug substance and drug product, including product inspection, and quality control laboratories.

The Specialist, Engineering will be responsible for providing validation support to the project as part of the Technical Operations Team. The successful candidate will be energetic and technically sound, with strong interpersonal, communication, and collaboration skills responsible for supporting FAT, IQ and OQ while specifically providing cycle development and PQ for equipment and supporting systems.

Responsibilities

• Provide validation support for drug substance and drug product technology transfer and qualification studies associated with the development and implementation of processes, systems, and facilities related to vaccine production

• Participate on cross-functional teams to advance projects goals and deliverables by providing contributions to the planning, design, and implementation of segments of new facilities, systems and equipment in a cost effective and timely manner

• Participate in the equipment specification, selection/procurement, and qualification phases of the capital project

• Develop technical and manufacturing documents necessary for development and validation studies in areas such as cleaning, sanitization, depyrogenation and sterilization. Lead study execution and author and present the associated documentation

• Lead validation topics in regulatory inspections by presenting and defending validation documentation. Author, review, and/or edit validation documents to support regulatory filings

• Author or update Validation SOPs

• Assist with troubleshooting and effectively resolving problems | Develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent recurrence | Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve it at root cause

• Maintain alignment with internal Technical personnel regarding validation practices for products, processes and equipment

• Partner with Operations, Quality, and Automation functional areas on validation study implementation

Education Requirements

• Bachelor degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline

Experience and Skills

Required

• Minimum two years relevant experience in validation, pharmaceutical operations, technical services, and/or quality operations

• Demonstrated ability to work in fast-paced, complex environments managing multiple priorities and escalate appropriately

• Authoring technical documentation within a cGMP context

• Demonstrates communication, technical aptitude, teamwork and problem-solving skills

Preferred

• Sterile cGMP in a biologics or pharmaceutical environment

• Facility, equipment, and process start-up in a sterile GMP environment

• Validation experience in support of GMP process demonstration (IQ/OQ/PQ)

• Lean/Six Sigma tools

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 …

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 …

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. #BCGExp

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here 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:

Relocation:

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Flexible Work Arrangements:

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Requisition ID:R124166