Drug Product Manufacturing Technician II, Fill/Finish operation

BeiGene, Ltd.; Hopewell (VA); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading global oncology company seeks a Drug Product Manufacturing Technician II for their Hopewell site. This role involves participating in the formulation, filling, and packaging of drug products in a cleanroom environment, ensuring compliance with cGMP standards. Ideal candidates are motivated team players with strong organizational skills and a commitment to quality and safety in manufacturing operations. Competitive hourly salary with comprehensive benefits package provided.

Benefits

Medical, Dental, Vision

401(k)

Paid Time Off

Wellness programs

Employee Stock Purchase Plan

Qualifications

• Prior industry or related field experience preferred.
• Ability to work in cleanroom environments and follow cGMP practices.
• Flexibility to work various shifts and manage heavy workloads.

Responsibilities

• Participate in drug product formulation, filling, and packaging processes.
• Support site validation protocol execution and report generation.
• Coach and train team members while executing floor operations.

Skills

Time Management

Problem Solving

Organizational Skills

Teamwork

Customer/Client Focus

Education

High school education or GED

Bachelor’s degree / Associate degree / Vocational school

Tools

Microsoft Office (Word, Excel, PowerPoint)

Job description

Drug Product Manufacturing Technician II, Fill/Finish operation page is loaded

Drug Product Manufacturing Technician II, Fill/Finish operation

Apply locations Hopewell time type Full time posted on Posted 14 Days Ago job requisition id R29676

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description

General Description:

The Fill/Finish Manufacturing Technician III position will work in a cleanroom environment and follow cGMP batch records and SOPs to manufacture drug products. Employees will support projects in conjunction with other GMP Manufacturing personnel (Leads, Supervisors, Managers). Employees will prepare suites for manufacturing operation and operate in a safe and compliant manner.

The primary responsibility of the Fill/Finish Technician III will be to participate in the execution of all phases and facets of drug product formulation, filling, visual inspection, labeling, and packaging. This will include requesting materials, setup, preparation, final filtration, and formulation, filling vials inside a Grade A isolator with an automated filling machine, labeling, visual inspection, packaging, document review.

Required Skills/Attributes:

• Demonstrated ability to successfully gown into aseptic manufacturing areas

• Excellent organization and time-management skills required

• Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure

• Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Self-Confidence & Ability to Accept & apply Lessons Learned as needed

• Works with a sense of urgency, while engaging and listening to experts

• Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills

• Strong organizational skills with the proven ability to prioritize

• Must be dependable and punctual

• Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word

• Must be flexible to work 1st or 2nd shift with holidays, weekends and overtime as per business needs

• Customer/Client Focus
  

Responsibilities:

• Support all site validation protocol execution and report generation

• Technical contact for team, customers, and vendors

• Support the team by coaching and training other team members

• Execute on the floor operations during clinical and GMP campaigns

• Enhance the safety of the organization through process/equipment improvements

• Part of equipment design and purchase

• Equipment start-up, troubleshoot, and perform acceptance testing

• Procedural design (SOP’s, MBR’s, etc.) and approval

• Write, initiate and review deviations

• Batch Record review

• Support drafting change record and CAPAs

• cGMP Manufacturing

  • Equipment cleaning and sterilization

  • Solution preparation and transfer

  • Equipment and process troubleshooting

  • Sterile Filtration / Integrity testing

  • Good Documentation Practices

  • Autoclaves and washers (equipment prep, cleaning and sterilization)

  • Familiar with Vial washer, Tunnel, Filling, Inspection and Packaging

  • DP equipment set up

  • Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace

  • Under the direction of the Production Supervisor, the Filling technician will work hands on, under ISO7, ISO8, ISO5 area and CNC with a variety of manufacturing production equipment and technologies

Physical Requirements:

• Must be able to stand for long periods, up to 8 to 12 hours/day.

• Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.

• Must be able to work scheduled 40 hours with the ability to work overtime as needed.

• Must be comfortable in working in varying temperatures.

• Frequent lifting, pushing, pulling, and carrying. Ability to lift to 40 lbs.

• Regular reaching, bending, stooping, and twisting.

• Repetitive motion and substantial movement of the wrists, hands, and/or fingers.

• Environment requires dedicated gowns, depending on area.

• Work with hazardous materials and chemicals.

• Willing to work any shift.

Qualifications:

• High school education or GED required

• Bachelor’s degree / Associate degree / Vocational school Preferred

• Prior industry or related field experience

Computer Skills: Familiarity with computer-based systems. Word, Excel, and PowerPoint a must.

Travel: International and domestic – periodically.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $27.45 - $36.45 per hour

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Similar Jobs (1)

Principal Scientist, Drug Product

locations Hopewell time type Full time posted on Posted 27 Days Ago

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 11,000 colleagues spans six continents. To learn more aboutBeOne, please visitwww.beigene.com and follow us onLinkedIn ,X (formerly known as Twitter),Facebook andInstagram .

To Mainland China Candidates

For more information, please visit the link to explore job opportunities in China Mainland.

At BeOne, how we work is just as important as the work we do. Below are our Values that determine the decisions we make and how we do things.