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 sign off 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
- 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
- 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
- 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)
- 2 - 4 years of experience in a manufacturing environment working with processing equipment and writing manufacturing procedures
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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