Specialist, Validation

Job Description

GENERAL INFORMATION

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

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 Performance Qualification (PQ) for equipment and systems supporting the Drug substance and Drug Product areas. The Validation 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, component prep (Autoclave and Parts Washer) 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 vaccine capital projects
• Collaborate with internal/external partners, e.g. Other of our 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.
• Participate in the feasibility activities working alongside Operation's team members to develop reliable, consistent manufacturing processes that meet cGMP requirements.
• Provide documented evidence that processes are consistent and reliable through challenges against pre-established criteria.
• 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.
• 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.

Education Minimum Requirement:

• Bachelor of Science Degree in Engineering or Life Sciences with a minimum of two (2) years of relevant experience.

Required Experience and Skills:

• Experience in pharmaceutical manufacturing within a cGMP environment
• Experience authoring technical documentation within a cGMP context
• Outstanding communication (written & presentation) skills
• 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 with facility, equipment, and process start-up in a sterile GMP environment.
• Sanitization and Sterilization validation (SIP, autoclaves, depyrogenation ovens, VHP)
• Cleaning validation (CIP, COP)
• Controlled Temperature Units (Refrigerators, Freezers, Incubators)
• Validation experience in support of GMP process demonstration (IQ/OQ/PQ)
• Air Visualization Studies (Smoke Studies)
• Sustaining the validated state through change management and continuing validation studies
• Strong technical problem-solving abilities
• 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

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.

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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".

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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):

Job Posting End Date:

*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:08/22/2024

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:R307878