Senior Aseptic Operator - 12 Hour Nights
Xellia

Job Info

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Would you like to join an award winning organization that is dedicated to saving lives?

In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment.

We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.

Is that you? If so, we want to learn more about you!

Position summary

Senior Aseptic Operator - RTU is part of Sterile Operations and is responsible is responsible for performing all necessary tasks both in and outside of the classified manufacturing suites in support of manufacture of safe and effective sterile (injectable) pharmaceutical products at CLE site in Xellia.

Key Responsibilities

• Perform job functions with in compliance of 21CFR part 210 and 211, FDA, OSHA and other regulatory agencies.
• Ensure that the current requirements for Environmental, Health, Safety (EHS) issues are met within the production operations.
• Ensure training compliance for assigned curriculum prior to performing any work task
• Set-up, Operation, and troubleshooting of key manufacturing equipment: including (but not limited to) lyophilizer, autoclave, parts washers, filler, capper, CIP/SIP skid, etc.
• Documentation of perform tasks as per established Good Documentation Practices, and review of executed documentation (batch records, logbooks, etc.) in a timely fashion
• Assist in the execution of equipment/process qualification, validation, and protocols as required.
• Assist in development and creation of departmental procedures to include but not limited to SOPs, OJTs, and work instruction documents
• Participate in investigations, and execute appropriate approved corrective / preventative actions for Aseptic Core related processes.

Requirements

• Required: HS Diploma/GED and 10+ years applicable experience
• Preferred: Bachelors of Science and 3-5 yrs applicable experience
• Advanced computer skills proficiency
• Military service highly desirable
• Automation and controls experience
• Demonstrated acuity to mechanical troubleshooting

• Candidate must be capable of physical movement with frequent bending and lifting up to 40lbs
• Candidate must be capable of extended periods of standing

• Candidate must physically be capable to successfully gown qualify
• Candidate will be required to wear PPE (Personal Protective Equipment), to include but not limited to respirator fit testing
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
• Candidate will not be permitted to wear (in the classified manufacturing areas) jewelry, makeup, hair extension, or any exterior adornment (religious articles will be evaluated on a case by case basis as to assess impact on controlled environment and drug product)
• All personnel shallbe required to disclose any health conditions that may have an adverse effect on drug products.
• Candidate will be required to work overtime as required
• Candidate must have demonstrated ability to organize and lead medium size interdepartmental or cross functional teams.
• Candidate must have demonstrated instances of advanced understanding and utilizing various business, quality and maintenance systems (i.e. Trackwise, MMS, LIMs, etc).
• Candidate must have demonstrated a high level understanding/execution of cGMP and GDPs, and is recognized as a compliance standard setter.
• Candidate will be required to assist in the authoring and revision of departmental SOPs.
• Candidate will assist as required in the training of operations personnel.
• Candidate will be required to fill in for supervisor during absences or periods that require delegation.

Physical Requirements of the role

Position is exposed to plant environment. This role is occasionally sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 50 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally. Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shallbe excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shallbe instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

Disclaimer

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Other duties and responsibilities assigned by management are considered incidental or secondary to the overall purpose of this job. Employees holding this position may be required to perform other job-related tasks as requested by management. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

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#LI-Onsite

Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company's evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
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