Función Laboral: Operaciones
Tipo de contrato: Jornada Completa
Ubicación: Arkansas - North Little Rock
Position Overview: The Process Engineer works in the Quality Assurance department. The primary responsibility is to provide processing expertise to the UP’s in developing the manufacturing procedures by which the formulation are produced.
- Work with RDP, Pilot labs (US and France) to develop SPs
- Enter and/or check off BOM of formulation in SAP
- Write manufacturing procedures in Mode OP based on the SP/SP received from RDP or Pilot plants
- Electronically signoff on the new manufacturing procedures (MFP) or any procedure modification by the ETNSH&E and the UP
- Get stability of any new formulation produced by a new SP or a procedure that is new to the plant
- Validate the MFP of the first three production batches send the results of the validation to the pilot
- If the officialization is marked yes for sending first production samples submit them to R&I on each shade of a new formula;
- Good knowledge of GMP/ISO requirements
- Send first production samples to Product Development for approval
- Assist the UP’s in purchase and validation for new Processing Equipment
- Write Performance Qualification protocols for OTC validation of any formula that is making an active ingredient claim. Reviews protocols from UPs for Installation Qualification and Operational Qualification for equipment validation
- Perform cake press testing on new powder formulations and establish pressing parameters
- Investigate all Out of Specification issues on bulk formulas
- Ensure GMP compliance of Processing/PW by performing routine audits
- Ensure FDA compliance of Process Expert related activities (validation of storage, validation of equipment, etc.)
- Write correction procedures for bulks that are authorized in the SP or Officialization to correct an out of specification issue
- Manufacturing pilot batches for shaded products for Liquids manufacturing
- Hold monthly right the first time meetings with the UP’s
- Send beginning movements of all new formulations for both bulk and finished goods. Send ending movements on bulks and finished goods that have been discontinued by R&I
- Provide CIQ with potential processing information for development of new or referenced SP’s
- Work with the UP’s to reduce batch time and make process improvements;
- Coordinate with Hygiene the sanitizing and cleaning validation on processing systems where water based formulas are manufactured;
- Perform special projects;
- Modify MFP’s to improve out of specification batches or improve production;
- Track new products;
- Other related duties as required.
- Actively engaged in safety initiatives in the plant.
Educational or Certification Requirements:
- Bachelor of Science and/or Engineering degree (preferable Chemical Engineering)
- 1-3 years of experience in a manufacturing environment working with processing equipment and writing manufacturing procedures
- Strong communication skills and capable of working with a diverse group of employees.
- Strong Microsoft Office skills
Tools and Equipment Used in Job/Environmental Factors:
- Must wear all proper Personal Protective Equipment (PPE).
- Machinery may produce noise levels that exceed OSHA’s action level: Employees are provided with and are required to wear personal hearing protection devices in these areas.
- Be self-motivated and work independently and as a team member, make decisions, and use adequate organizational and time management skills
- Have the ability to manage team and to work well in a cross-functional team
- Communicate effectively, both orally and in writing, and build positive work relationships with all levels of the organization
- Must follow the Piscataway Manufacturing Compass:
- Take 100% responsibility for choices
- Be committed to team decisions
- Accountability for ourselves and others
- Punctuality with commitments
- Create a safe environment that encourages healthy conflict
- Foster teamwork and pack parachutes
- Bring solutions to solve problems, no matter how difficult
- Must implement and utilize the Piscataway Manufacturing communication model.
- Must follow the Piscataway values:
- Must produce World Class Results through teamwork.
- Must thrive within a changing organization.
- Must create and provide an environment in which employees can work safely and thrive.
- Must act as a responsible citizen in our company and community.
- Must be able to make rapid decisions.
- Must listen for understanding.
- Must have a positive attitude.
We are an Equal Opportunity Employer and take pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.
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