Formulation Process Operator

Shifts
2nd - 8 hour shift, M - F, 2p - 10:30p
2nd 10 hour shift, T - F, 2p - 1230a

Please indicate the shift interest just as we did on the previous reqs. Please identify workers for both shifts. There is only one position open per shift

Adhere to cGMP, SOP, and site safety procedures in order to operate, assemble, disassemble, and clean essential pharmaceutical manufacturing and testing equipment. Effectively communicate with management, peers, and other
support areas to ensure effective operations, as well as identify and improve on applicable standards. Provide clear written documentation on all production related activities, as well as event responses, in applicable systems. Use Lean practices and tools. Must be able to lift up to 50 lbs and use a pallet jack. Must be able to wear PAPR, steel-toed shoes, and safety glasses for extended periods of time.

In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title:

* In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and / or tasks, etc. associated with this job title:

* Comply with cGMP's, SOPs and site safety procedures, as well to follow good housekeeping rules.
* Communicate and work collaboratively within a team to achieve operational delivery within a complex or multidisciplinary production environment to meet monthly/weekly demand requirements
* Demonstrate ability to properly operate equipment, perform equipment set-up/change-over/clean-ups, assist in preventative maintenance and perform minor equipment troubleshooting in a safe and efficient manner.
* Verify raw materials, components and products meet the product specification and are available to meet the agreed production schedule
* Responsible for visual inspection, cleaning (including quarterly cleanings) and tightening of equipment.
* Utilize Standard Work Instructions and escalate issues and opportunities to improve. Responsible for execution and improvement of changeover of formulation assets including, assembly / disassembly, and center line adjustment to optimize equipment performance, where appropriate.
* Provide ownership of the process & equipment performance (OEE).
* Use a continuous improvement mindset, alerts supervision of any irregularities in procedures or equipment operations.
* Partner with other Operators/Mechanics/Technicians/Facilitators/Engineers to correct.
* Accountable for accurately and contemporaneously documenting formulation and cleaning activities in batch records/electronic batch records, paper or electronic Logbooks, and within applicable performance tracking systems (Traksys, Discoverant, etc.)
* Can lift up to 50 lbs, push/pull large vessels and carts, and transfer full drums off of and onto a pallet.
* Use a pallet jack to transport pallets.
* Must be comfortable wearing a Powered Air Purifying Respirator (PAPR) while working in the process area.
* Attend regular SHE, GMP, PET (FIT) and Site meetings.
* Able to work other shifts, weekends, alternative schedules when production demands require.
* Able to perform duties with minimum supervision.
* Able to demonstrate good interpersonal skills and work in a robust team environment, with other operators, mechanics, technicians, supervision and project management with the goal of completing planned production and furthering Newark Site and *** initiatives.

Note there is a cleaning commitment with this role. This includes sterilizing equipment and team deep cleanings of work stations once a month in effort to maintain the cleanliness of the lab.

Note this role requires deep team work. This is not similar to a packaging role in a warehouse. The packaging component of this role includes labelling, and concentrated procedures

Education
* High School Diploma
* Demonstrated problem solving and troubleshooting skills


Experience

* Experience in a production environment
* Knowledge of pharmaceutical cGMP's
* Basic mechanical aptitude
* Basic computer skills
* Good interpersonal, communication and writing skills
* Ability to preform duties with minimal supervision




Dress Code

Our attire guidance for the Newark site can generally be described as Casual Dress (not quite business casual).

What does "casual dress" mean? First, employees must use good judgment and common sense. We are a professional place of work, host many guests and visitors, and expect a respectful working environment. Jeans, slacks, sport shirts, polo shirts with collars, sweaters, t-shirts, and sweatshirts are all examples of casual dress for our site.

Clothing items that are not permitted include gym clothes, shorts, cutoffs, jogging outfits, biker shorts, tank tops, jeans with have rips, paint splatter, are excessively baggy or bedazzled, and shirts with inappropriate comments or images.

Additionally, some areas on site strictly prohibit the wearing of dresses, skirts, open-toed shoes, and other similar clothing items that expose for safety purposes.


COVID Vaccination Required