Senior Specialist, 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.

Position Description:

GENERAL INFORMATION

We have an exciting opportunity for a Senior Specialist to join the technical operations team for a capital project start-up in Durham, North Carolina. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, filling, lyophilization, product inspection, and quality control laboratories. The Senior Specialist, Validation engineer is responsible for providing technical support to one of the vaccine manufacturing areas within Technical Operations.

POSITION OVERVIEW

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 Process Qualification (PQ) for equipment and systems supporting the Drug substance and Drug Product areas. The Senior Specialist will primarily support the drug substance and drug product site readiness via Validation program implementation, partnering with cross-functional teams (i.e. Maintenance, Global Engineering, Quality, and Operations) to ensure a successful technology transfer, filing, and licensure for a new Bladder Cancer drug substance and drug product manufacturing facility.

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:

• Provide validation support for commercial technology transfer and qualification studies associated with the development and implementation of processes, systems, and facilities related to vaccine drug substance, key intermediates e.g., media and cleaning solutions and drug product e.g., vial washing, depyrogenation, filling, lyophilization.

• 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 capital projects

• 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.

• Develop technical and manufacturing documents necessary for development studies required for media and non-porous loads autoclaves.

• Participate in the feasibility activities working alongside Operation's team members to develop reliable, consistent manufacturing processes that meet current Good Manufacturing Practices (cGMP) requirements.

• Provide documented evidence that processes are consistent and reliable through challenges against pre-established criteria.

• 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.

• Provide contributions to the planning, design, and implementation of segments of new facilities, systems and equipment in a cost effective and timely manner.

• 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 in authoring the regulatory submission for the facility and present your work to multiple regulatory agencies throughout the pre-approval inspection processes.

• 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.

• Provides on-the-floor support of operational and technical (process/equipment) issues on the shop floor.

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, VHP)

• Cleaning validation (CIP, COP), Parts Washer

• 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

Travel: Up to 20% of the time

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., Rahway, 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.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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US and Puerto Rico Residents Only:

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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.

Residents of Colorado:

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R211865