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Job Description

Our Engineers support internal and external manufacturing operations to remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biologics, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Position Description:

GENERAL INFORMATION

A Senior Engineer will provide organizational support and technical leadership for the Teknika manufacturing area in Durham, NC. The Validation group at Teknika is a group comprised of 6 scientists and engineers and must demonstrate strong technical and project management skills. The individual must embrace an empowered team culture.

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

POSITION OVERVIEW

The successful candidate will be energetic and technically sound, with strong interpersonal, communication, and collaboration skills responsible for supporting PQ and requalification activities for multiple pieces of equipment. The Senior Specialist will primarily support vaccine drug manufacturing via Validation program execution and partnering with cross-functional teams (i.e. Maintenance, Quality, and Operations) for continued process manufacturing.

Additionally, this role will contribute to the performance and results of a department, provide validation guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Off-shift and weekend coverage will be required at times based on business unit needs and specific assignments.

Specific assignments may be focused in one area or span across multiple areas of focus.

Responsibilities may include but are not limited to:

• Partner with Teknika Technology, Operations, Quality and Maintenance teams to deliver tactical and strategic projects as needed.

• Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the vaccine process.

• Lead validation studies and author the associated documentation

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

• Collaborate with internal/external partners, e.g. Other Company sites, Procurement, Raw Material & Component Suppliers

• Author, review, and/or edit validation documents to support regulatory filings

• Support Change Control documentation for complex process, validation, analytical, equipment, facility/utility and/or automation changes.

• Lead validation topics in regulatory inspections by presenting and defending validation documentation.

• Develop technical and manufacturing documents necessary for development studies, cleaning, sanitization, depyrogenation and sterilization process validation.

• May be responsible for leading teams of contractors to efficiently accomplish project goals.

• Provide technical support to help develop and execute project plans; and obtain and analyze relevant data and prepare appropriate reports for regulatory submissions.

• Design validation studies, author and approve protocols, and ensure alignment with corporate standards and site guidance for validation.

• Serve as mentor for less experienced teammates, assisting with technical development.

• 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. The successful candidate should be able to 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.

Position Qualifications:

Education Minimum Requirement:

• Bachelor of Science Degree in Engineering or Life Sciences with a minimum of five (5) years of relevant experience;

• or a Master of Science Degree with a minimum of three (3) years of relevant experience;

• or a Ph.D. with relevant academic experience.

Required Experience and Skills:

• Experience in pharmaceutical manufacturing within a current Good Manufacturing Practices (cGMP) environment

• Experience authoring technical documentation within a current Good Manufacturing Practices (cGMP) context

• Demonstrated effective written and verbal communication skills

• Experience with project strategic plan development and management

• Demonstrated ability to work both independently and as a part of a team

Preferred Experience and Skills:

• Experience in bulk upstream and/or downstream vaccine processes within a current Good Manufacturing Practices (cGMP) environment

• Experience with facility, equipment, and process start-up in a sterile current Good Manufacturing Practices (GMP) environment.

• Sanitization and Sterilization validation (SIP, autoclaves, depyrogenation ovens)

• Cleaning validation (CIP, COP)

• Validation experience in support of Good Manufacturing Practices process demonstration (IQ/OQ/PQ)

• Sustaining the validated state through change management and continuing validation studies

• Strong technical problem-solving abilities

• Familiarity with regulatory requirements

• Experience with responding to regulatory questions with multiple agencies (e.g. FDA, EMA)

• Experience with face to face presentation of technically complex subjects to regulatory inspectors

• The ability to work well under pressure and achieve results within tight deadlines

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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.

Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

06/28/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date: 06/28/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R298340