Equipment Engineer

Equipment Engineer

BCforward is currently seeking a highly motivated Equipment Engineer for an opportunity in Warren, NJ.

Job Title: Equipment Engineer

Job Location: 7 Powder Horn Drive - Warren, New Jersey 07059

Duration: 6+ Months

Pay Range: $50 - $54/Hr. on W2

Job Description:

Our client, a leading pharmaceutical company, is hiring an Equipment Engineer, on a contract basis.

Summary:

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.

Education/Experience:

• BS in Engineering or Science related discipline preferred.
• 3 years of experience in FDA-regulated industry.
• 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.

Knowledge/Skills:

• Knowledge of cGMP, GXP, GAMP, 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 multitasking 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, e.g., Blue Mountain RAM and/or Maximo Computerized Maintenance Management System (CMMS) preferred.
• Ability to interact effectively with QC, Manufacturing, QA, and Engineering & Facilities groups.

Responsibilities:

• Executes equipment calibration, preventative maintenance, performance verification, troubleshooting and repair activities in laboratory and manufacturing areas, as required per current scheduling (CMMS) System.
• Escorts and supervises vendors for calibration, preventative maintenance, performance verification and repair functions as required per current scheduling (CMMS) System.
• Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness.
• Documents and populates calibration/maintenance information in WPT (Work Plan Template) or MDT (Measurement Data Template) using CMMS system.
• Modifies or update CMMS documentation as required.
• Prepares reports and keeps records on calibration inspection, testing, and repairs.
• Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20C / -80C Freezers), Incubators, Cryotanks, Cryopods, and Storage Rooms/Areas).
• Supports multiple sites within Warren and Summit.
• Supports clinical manufacturing on-call equipment troubleshooting activities during weekends as required.
• Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
• Contacts supplier for quotation on external calibration/PM of the equipment and calibration standards
• Initiates, participates, and assists in resolution of quality investigations.
• Authors and supports the development, revision, and review of written Standard Operating Procedures (SOP) for calibration, preventive maintenance, and performance verification of instruments/equipment.
• Supports 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.
• Performs inventory of the equipment and/or standards in the labs as required.
• Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment.
• Participates actively in special projects as required.
• Ensure low cost of the Laboratory Systems Management (LSM) department (Reducing overtime, implementing innovative ideas)
• Plans, justify and implement cost reduction small projects.
• Usage of several test equipment and tools (e.g., pressure gauges, temperature, humidity meters, flow meters, particle counters and temperature mapping equipment etc.)
• 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.
• Support the development, review and approval of calibration and maintenance plans in site CMMS system.
• 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.
• 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 NCRs investigations.
• Review and approve calibration and maintenance work.
• 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.

Benefits:

BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.

About BCforward:

Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward's 6,000 consultants support more than 225 clients globally.

BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.

BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.

Interested candidates please send resume in Word format Please reference job code 237562 when responding to this ad.

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