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Manufacturing Process Engineer

Company: TriStaff Group of Companies
Location: Carlsbad
Posted on: August 7, 2022

Job Description:

Position and ScopeThis position reports to the Director Technical Operations and will be responsible for providing expertise and guidance in the field of reagent formulation, filling and finishing activities for the Molecular Diagnostics & Life Sciences manufacturing segment of our services. This individual will be a hands-on and be directly involved with floor technicians to ensure proper techniques and guidelines are being followed. Specific Skills --- Ability to train operators on manufacturing processes to improve productivity and reduce run times.
--- Ability to multi-task in a fast-paced environment, and transition from one assignment toanother with minimal training and direction from supervision.--- Strong computer skills. Familiar with MS Excel, Word, and PowerPoint.--- Ability to draft and/or collaborate on SOP's, NCR's, Deviation's, Work Instructions.--- Knowledge of cGMP, ISO, and FDA Regulations, specifically 21 CFR - Part 820, ISO 13485, and ISO 14971.--- Proven ability to thrive and enable success in a cross-functional and collaborative environment.--- Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
--- Desire to work with all departments to implement change.--- Ability and willingness to work flexible/extended hours if needed. --- Physical Demands include standing stooping, bending, pushing, kneeling, stretching, extensive walking.--- May require lifting of objects whose weight normally will not exceed 35 pounds General Responsibilities --- Actively work with Manufacturing to solve challenges in the production environment.--- Support agency inspections and client audits relating to Molecular Diagnostics & LifeSciences, ensuring compliance with policies, procedures, and regulatory requirements.--- Resolve day to day issues within functional departments and aid as needed.--- Review and approve qualification and validation protocols and reports for equipment and processes related to Molecular Diagnostics & Life Sciences products.--- Lead and assist in performing all tasks necessary to achieve the organization's mission and help execute growth.
--- Ensure continuous improvement and effectiveness of the manufacturing processes. Position Requirements and Experience --- Bachelor's degree in a relevant scientific discipline such as chemistry, biology, or pharmaceutical sciences or engineering preferred, however relevant experience will be considered in lieu of education.--- Successfully served in a similar capacity in a contract manufacturing company for a highly regulated market, preferably the life science/pharmaceutical environment.--- Experience and familiarity in reagent formulation, filling and finishing activities with 2 -4 years of directly related accountability for quality in this form of manufacturing.--- Consistently exhibited through their actions, decisions, and interactions (internally and externally), the highest standards of ethics and integrity.--- A proactive style using initiative and perseverance in order to bring about meaningful change.

  • --- Familiarity with Lean Manufacturing cultures in a volume production facility.

Keywords: TriStaff Group of Companies, San Diego , Manufacturing Process Engineer, Engineering , Carlsbad, California

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