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Description:
Job activities include the preparation of equipment and components for aseptic filling operations, performing visual inspection of filled vials, vial labeling, vial packaging and distribution of filled vials as per GMP regulations.
- Execute daily tasks such as washing and sterilizing vials and filling components for use in production operations.
- Perform area clearance on equipment and rooms that involve cleaning, and integrity testing pre/post production.
- Perform Aseptic filling operations and dynamic monitoring/sampling inside various isolators.
- Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP).
- Record Activities in production batch records, and equipment logbooks as well as updating and/or authoring SOPs.
- Review documentations and check all calculations.
- Maintain an inventory of manufacturing supplies and order additional materials as necessary.
- Assist in activities related to other onsite departments such as the execution of validation protocols.
- Comply with all applicable health, safety and environmental policies promoting a safe workplace to prevent or reduce injuries.
- Perform tasks under minimal supervision, and within tight time lines to meet production schedule.
- Report any unexpected observations and suggest possible explanation and resolution.
Additional Skills & Qualifications:
- BS/BA in Biology, Chemistry, or related discipline
- 1-2 years’ experience in a GMP facility or High School Diploma and at least 4 years’ experience in a GMP facility.
- Good interpersonal skills and attention to detail.
- Previous experience working with aseptic technique and good documentation practices preferred.
- Must be able to follow cGMP regulations during operations including adherence to written procedure and contemporaneous documentation.
- Must be able to record data accurately and legibly.
- Demonstrated mechanical aptitude.
- Ability to perform in a team setting in a controlled environment for long periods of time.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
