Come join Mycoscience and become part of a company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!

Headquartered in Willington, Connecticut, Mycoscience is part of Millstone Medical Outsourcing, a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Mycoscience has over 30 years of expertise in medical device and pharmaceutical laboratory testing, environmental testing, and related regulatory support services. Mycoscience is an ISO 13485:2016 certified contract manufacturing organization operating out of an FDA-registered facility with a rigorous approach to quality that upholds Millstone’s commitment to operating under the highest quality standards.

What's in it for you?

A company committed to quality, growth, career pathing.

At Mycoscience, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.

Total Rewards Benefits Program:

• Medical - Starting on the 1st day of employment
• Dental - Starting on the 1st day of employment
• Vision - Starting on the 1st day of employment
• Supplemental Benefits - Life, Disability, Critical Illness
• Paid Time Off
• Tuition Reimbursement
• Career Pathing
• 401(k) with match

To learn more about Mycoscience visit us online at https://mycoscience.com/

Position Overview:

Aseptic Filling Technician of Medical Devices as part of our Production side of the company. The major accountability for this position is to run the entire production run from preparation to packaging - producing final medical device product. All activities are closely supervised and work is reviewed upon completion. The work schedule is Monday through Friday, 8-4:30pm.

Key Responsibilities:

· Prepare and run filling line for vial and syringe filling operations.

· Prepare all process specific equipment for use in assigned areas.

· Operate equipment in compliance with SOPs.

• Understands all aspects of the washing, filling, component sterilization process and operation of the process equipment within this respective area.
• Operates in ISO Class 6/7/8 environments and conduct routine aseptic interventions.
• Aseptic Filling Technician reports to Operations.
• Performs necessary machine set-up, operation, changeover, adjustment, diagnosis, repair, and preventative maintenance on production equipment.
• Responsible for minimizing production line down time and maximizing efficiencies. Highly proficient at mechanical and electrical system troubleshooting.
• Communicates openly and clearly with line personnel and supervision to accomplish manufacturing goals.
• Follow SOPs, cGMPs, batch records, BOMs.
• Notify Group Leader/Supervisor of all safety and quality issues.
• Documents all maintenance performed through the use of the work order system and maintenance log books.
• Keeps accurate GDP records as needed for filling manufacturing and prepares the process steps and parameters with the utmost attention to detail as specified in the batch record
• Provides recommendation and plan of action to the supervisor on the needed repair of the equipment
• Ensure that environmental excursions are kept to an acceptable level.
• Must have a good working knowledge of the batch record.
• Load and operate process sterilization equipment per approved loading and placement diagrams

· Must be able to articulate aseptic techniques and processes to the highest level of management

Basic Qualifications:

· High school diploma/GED or Biotech certificate with a minimum of 1 year experience in cGMP manufacturing environment or bachelor’s degree and minimum of 1 year of experience in cGMP manufacturing environment

· Experience with aseptic processing.

· Knowledge and demonstrated understanding of GMP and how it applies to specific responsibilities and manufacturing operations.

· Excellent communication and collaboration skills.

· Self-motivated, detailed oriented, have the ability to manage own time, be flexible, team oriented, and demonstrate good troubleshooting skills.

· Experience in writing SOPs.

Preferred Qualifications:

· Bachelor’s degree in Biology, Chemistry, Biochemistry, or Chemical Engineering.

· Strong verbal and written communications, effective time management, and organizational skills are essential to success in this role.

· Visual inspection experience.

Special Working Conditions:

· Ability to lift up to 50 pounds.

· Push/pull up to 50 pounds to move loaded, wheeled carts with assistance from another worker.

· Frequent sitting, walking, standing, bending and squatting.

· May require standing and walking up to 70% of day.

· Frequent reaching between waist and shoulder level.

· Occasional reaching up and out.

• This position requires adherence to all SOPs, cGMP, and site quality, safety, and documentation.
• Other related duties essential to these operations or special assignments as required.
• Operates all production equipment.

ADDITIONAL INFORMATION:

Mycoscience and Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to commute/relocate:

• Willington, CT 06279: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Chemistry, manufacturing & controls: 1 year (Preferred)

Work Location: In person

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