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Technical Operations Specialist

3 months ago

Arvada, Colorado, United States Merck Full time

Job Description

We are seeking a Growth and Improvement minded Technical Operations Specialist | Vaccine Manufacturing that can help drive our Strategic Operating Priorities.

    • Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
    • Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
    • Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
    • Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
    • Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Technical Operations Specialist | Vaccine Manufacturing will work at our Company's largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and/or final dosage forms for all company vaccine products and is growing to meet the vaccine demands of the future.

The Syringe Filling Facility Project Team is seeking a highly motivated individual to fill an open position in the Sterile Product Inspection Suite Team to lead the start-up of a new vaccine filling and inspection facility. Facility start-up will include commissioning, equipment qualification and vaccine drug product process demonstration in support of facility licensure. The Technical Operations Specialist | Vaccine Manufacturing will be an energetic team member with strong collaboration skills responsible for partnering with multiple functions to execute facility design, construction, startup and operational readiness in the Sterile Product Inspection Suite. Upon completion of the facility commissioning and qualification this individual will become the Technical Operations Visual Inspection SME for the facility, with responsibility to drive all visual inspection related process improvement and qualification activities.

Key Functions

    • Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
    • Execute initial inspection recipe development and qualification to support Process Performance Qualification efforts
    • Optimize product specific automated inspection programs for detection of defective material and reduction of product discards
    • Upon startup of routine manufacturing, provide on-the-floor support of operational and technical issues related to Inspection equipment
    • Authors and updates technical and manufacturing documents necessary for support of investigations, process design/definition, engineering studies, process demonstrations, change control and validation.
    • Provide operational and technical expertise for design reviews, process hazard assessments, quality risk assessments, factory and site acceptance testing, qualification
    • Support digital and data integrity initiatives for the project
    • Develop and assure consistent application of standardized work, engineering, and process tools
    • Support regulatory submission preparation and inspections for the facility
    • Effectively collaborate with a work team while motivating others, ensuring performance, schedule execution, task coordination, equipment and area preparation and effective administration of personnel policies and procedures
    • Create and maintain Inspection related SOP's, Standard Work Documents, E-Logs, Manufacturing Batch Records, E-learning courses and training materials
    • Participate in training of employees and qualification of the Automated Inspection / End of Line equipment
    • Assure compliance with safety and environmental practices, cGMPs and SOPs in the work area

Dynamic Advances in Science & Technology Necessitate New Methods of Production

    • Collaborate with team members to implement continuous improvement initiatives
    • Support activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence and lean practices
    • Utilize lean principles and six sigma methodology to solve problems while working in teams
    • Facilitate implementation of corrective actions to correct past performance, proactively identify safety and quality-related trends
    • Recognize and investigate opportunities for financial savings

Education

    • Bachelor degree in Engineering, Science, or other related technical field of study

Required

    • Principled verbal and written communications
    • One year GMP manufacturing experience or other heavily regulated industry (example: FDA, military, nuclear, and petro-chemical)
    • Strong planning, scheduling, analytical and time management skills

Preferred

    • Previous experience in pharmaceutical automated vision inspection systems
    • Change control experience
    • Two years experience in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.) or a heavily regulated industry
    • Lean Manufacturing experience
    • Facility startup experience

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.

VETJOBS

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

Current Contingent Workers apply HERE

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.

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:

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EEOC GINA Supplement​

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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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

06/1/2024

*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:06/01/2024

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:R293406