Bio Process Technician - 2nd Shift

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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 linked to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products.

Position Description:

The Bio-Process Technician is accountable for providing shop floor operations and environmental monitoring support to aseptic manufacturing within the vaccine manufacturing facility. Tasks will include formulation, aseptic primary filling, inspection, packaging, and CIP/SIP. This position will also perform various roles to include executing routine room and equipment disinfection as well as managing the movement of gowning, disinfectants, and materials. In addition to supporting operations activities, the role will be accountable for ensuring that EHS and GMP compliance is maintained within their area of assignment. This position will be an individual contributor and member of the Operations team.

Delivery

• Execute manufacturing operations, environmental monitoring, and facility disinfection

• Set up and operate vaccines formulation, aseptic primary filling, inspection, packaging, CIP/SIP, and additional equipment within qualified parameters

• Identify potential equipment problems and partner with Vaccines Maintenance Technicians to ensure appropriate resolution. Demonstrate ability to troubleshoot process, electronic systems, and equipment for routine and basic problems.

• Perform other duties as requested by the Operations coach

Compliance

• Accountable for performing work in a safe manner, following identified safety procedures (hazardous work permitting, LOTO, HECPs), and using applicable safety equipment / personnel protective equipment (PPE)

• Execute operations functions in accordance with current Good Manufacturing Practices (cGMPs) and standard operating procedures (SOPs)

• Complete documentation in batch records, electronic logs, or other systems in accordance with site procedure

• Maintain good housekeeping and 5S in assigned work area

• Adhere to the highest level of data integrity while performing duties

• Identify potential quality or safety issues. Escalate as per IPT management processes and assist in the investigation, root cause determination, and CAPA implementation.

Cost

• Ensure that startup activities for area of assignment are executed such that project deliverables and timelines are met

• Closely monitor team / process performance and improve reliability through problem solving and continuous improvement

• Set up and operate equipment in alignment with established training and procedures to ensure reliable operation with minimal delays or discards.

• Identify and help implement continuous improvement and productivity enhancements within the IPT

Team

• Partner with Technicians and cross-functional groups for assigned area.

• Demonstrate a high degree of maturity and personal integrity. Strictly adhere to all site policies on personal conduct and attendance.

• Train, develop, and mentor other team members to share experience and best practices

• Pursue knowledge and skills in assigned area from an operations perspective and share that information readily with team.

• Maintain a culture of continuous improvement / MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving

• Routinely demonstrates leadership and conflict-resolution ability. Demonstrates a willingness to provide and receive constructive feedback in 360 performance review.

Reporting Relationships:

• Solid line report to: Manager, Maintenance & Operations

• Dotted line report to: N/A

• Position(s) reporting to this position: N/A (individual contributor)

Position Qualifications:

Minimum Education Requirement:

• High School diploma or equivalent minimum.

Required Experience and Skills:

• Two (2) or more years of experience in a GMP manufacturing facility (aseptic GMP environment strongly preferred).

• Demonstrated ability to work independently as team member

• Demonstrated interpersonal skills with ability to influence and assist others through a culture of inclusion, feedback, and empowerment

• Demonstrated leadership ability, peer training experience, and/or productivity improvement activities strongly preferred.

• Ability to gown and work in an aseptic environment

• Demonstrated ability to work with computerized and automated systems.

• Willing to work irregular hours to support multi-shift operation on an as needed basis

Preferred Education, Experience and Skills:

• Associates degree in Business, Science, or Technology-based field and/or bio-pharma focused certificates such as Bioworks preferred.

• Experience with aseptic filling, visual inspection systems, CIP/SIP systems, packaging equipment and similar aseptic formulation and filling operations

• Experience operating, maintaining, troubleshooting, and/or repairing industrial equipment

• Experience working in a regulated environment (FDA, etc.) and basic knowledge of cGMPs as they apply to the vaccine/pharmaceutical industry

• Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies

• SAP / MES / electronic logbook basic knowledge from a production execution perspective

• Demonstrated ability and drive to work autonomously and help organize priorities and work with other team members

• Outstanding communication skills both within direct team and across multiple shifts to ensure success of overall team

• Ability to support technical writing of documents such as standard operating procedures (SOPs)

Our Manufacturing & Supply Division is dedicated to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s 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 …

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.

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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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 another’s 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., 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:R179820