- The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers.
- The incumbent conducts tasks assigned by the management independently or with minimum supervision.
- The LSM Equipment Engineer is responsible for initiating and owning deviations, CAPAs, and change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations.
- Executes equipment calibration, preventative maintenance, performance verification and repair activities in laboratory and manufacturing areas.
- Supervises vendors for calibration, preventative maintenance, performance verification and repair functions.
- Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness.
- Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
- Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20°ree;C / -80°ree;C Freezers), Incubators, Cryotanks, and Cryopods).
- Supports multiple sites.
- Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.
- Authors and supports the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment.
- Support the development, review and approval of calibration and maintenance plans in site CMMS system.
- Supports the execution of process improvement studies, as required.
- Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards.
- Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment.
- Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available.
- Inventory Management
- Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed.
- Approves Change Request, Asset Inductions, and Work Request.
- Approving Calibration and Maintenance forms.
- Perform NCR's investigations.
- Review and approve calibration and maintenance work.
- Regulatory Responsibilities
- Maintains all required Corporate, Facilities and EHS training as required.
- Adheres to all safety procedures and hazard communication.
- May be called upon to act as SME in both internal and regulatory audits.
- Occasional lifting up to 25 lbs.
- Environment may include working in office, laboratory, or manufacturing area.
- Donning proper gowning and/or PPE such as safety glasses and shoes in an environment with hazardous materials and waste will be required.
- Working safely and effectively when working alone or working with others will be required.
- BS in Engineering or Science related discipline required
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
- Knowledge of calibration management and environmental monitoring systems.
- Strong critical thinking skills and the ability to work independently.
- Excellent interpersonal and communication skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
- Strong multi-tasking and organizational ability.
- Ability to effectively manage multiple tasks and activities simultaneously.
- Proficiency in Microsoft Office Suite - Word, Excel, PowerPoint, and Outlook; innate ability to learn new software, such as corporate intranet and enterprise applications.
- Working knowledge of scheduling software and systems, and inventory management systems, Blue Mountain RAM and Maximo preferred.
- Ability to interact effectively with QC, Manufacturing, QA, and Facilities groups.
- Minimum 3 years of experience in FDA-regulated industry.
- Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.)
- Maintenance coordination / planning experience preferred.
- Experience working in a clinical environment preferred.
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LSM Equipment Engineer - Warren, United States - Synectics Inc
Description
Job Description
Job DescriptionDescription:
Qualifications:
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
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