Job Description

Job Description

The successful candidate will be energetic and technically sound, with strong communication and collaboration skills responsible for supporting Factory Acceptance Test (FAT), IQ and OQ while specifically providing cycle development and PQ for equipment and systems promoting bulk biological processes (i.e. Sterile Supply, Adjuvant Manufacturing, Fermentation, and Purification). This position will primarily support vaccine drug substance 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 vaccine drug substance 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.

Primary Responsibilities

* Provide validation assistance for commercial technology transfer and qualification studies associated with the development and implementation of processes, systems, and facilities related to vaccine drug substance and key intermediates e.g. buffers, media and cleaning solutions

* 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

* Partner with internal/external partners, e.g. other Company sites, Procurement, Raw Material and Component Suppliers

* Author, review, and/or edit validation documents to assist with 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 assistance 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 comprehend 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

* Pharmaceutical manufacturing within a cGMP environment

* Authoring technical documentation within a cGMP context

* Outstanding communication (written and presentation) skills

* Demonstrated effective written and verbal communication skills

* Project strategic plan development and management

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

Preferred Experience and Skills

* Bulk upstream and/or downstream vaccine processes within a cGMP environment

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

* Sanitization and Sterilization validation, i.e. SIP, autoclaves, depyrogenation ovens, Vaporized Hydrogen Peroxide (VHP)

* Cleaning validation (CIP, COP)

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

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

* Strong technical problem-solving abilities

* Replying to regulatory questions with multiple agencies (e.g. FDA, EMA)

* Face to face presentation of technically complex subjects to regulatory inspectors

* Ability to work well under pressure and achieve results within tight deadlines

Travel

* Up to 20% of the time

DurhamQuality

DurhamEng

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 thats 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.

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 if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

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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 anothers 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:

25%

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Number of Openings:

1
Requisition ID:R96906