Student Veterans of America Jobs

Welcome to SVA’s jobs portal, your one-stop shop for finding the most up to date source of employment opportunities. We have partnered with the National Labor Exchange to provide you this information. You may be looking for part-time employment to supplement your income while you are in school. You might be looking for an internship to add experience to your resume. And you may be completing your training ready to start a new career. This site has all of those types of jobs.

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Job Information

Merck Associate Director, Deviation Management in Durham, North Carolina

Job Description

If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

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.

The Deviation Management Associate Director, Engineering will provide organizational support and technical leadership for the formulation and fill manufacturing facility in Durham, NC. The Deviation Management Lead reports to the Site Technical Lead and is a member of the Technology Leadership Team. The lead will manage a group of up to 22 scientists and engineers and must foster strong technical writing, problem solving skills, data analysis, and development and evaluation of strong corrective and preventative actions based on investigation findings. The individual must embrace and be committed to establishing an empowered team culture, with the goal of each employee reaching their fullest potential and having accountability, authority and responsibility to one another, our community and our patients.

Key Responsibilities

  • Manage, inspire and influence team through troubleshooting to effectively resolve manufacturing atypical events. Ensure that corrective actions to unplanned (atypical) manufacturing events result in consistent and reliable supply and prevent recurrence

  • Lead organizational efforts to continuously improve deviation management performance and outcomes

  • Support regulatory audits with coaching Subject Matter Experts (SMEs) and presenting to auditors

  • Represent department and site on cross-functional teams

  • Stay well informed of current trends in industry, and innovate to drive continuous improvement

  • Manage group budget within financial targets

  • Develop, coach and mentor direct staff and junior members of broader Technology organization

Education Requirement

  • Bachelor degree in Engineering, Sciences or related field

Experience and Skills

Required

  • Minimum eight years in a technical role (6 Years with a Masters Degree or MBA; 4 years with a PhD)

  • Strong and effective planning, scheduling, and time management skills

  • Working knowledge of regulatory requirements in accordance with GMP manufacturing operations

  • Principled verbal and written communication skills

  • Interacting with regulatory inspectors

  • Familiarity with Change Control systems (i.e. Trackwise) and equipment qualification and validation

  • Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols

  • Expert problem solving and technical writing skills

  • Demonstrated ability to manage multiple medium to large projects and initiatives

  • Six years’ experience in pharmaceutical, biotech or other regulated industry

Preferred

  • Formal problem solving techniques and a hands-on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools

  • cGMP in a sterile, vaccine, bulk or finished pharmaceutical environment

  • Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment validation

  • Direct interactions with regulatory agencies from countries around the world

  • People-management experience a plus

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 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.

Residents of Colorado

Click here (https://survey.sogosurvey.com/Survey1.aspx?k=SsQYWYYQsQRsPsPsP&lang=0) to request this role’s pay range.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

Pay Transparency Nondiscrimination

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:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R144473

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