14342176
Located in Parsippany, NJ
Job Full Description
Scope:
The Mechanic I will provide operational support to process equipment and systems. The position requires experience in GMP production with a primary focus on the process equipment and systems used in the manufacturing. The Mechanic I will also provide supplemental support to the GMP/clean utilities (water, compressed air, HVAC, and environmental chambers) as needed.
Responsibilities & Duties:
· Provide support for all process equipment related troubleshooting, elevate to plant engineer as needed.
· Provide supplemental troubleshooting support for utility systems as needed
· This individual must be able to read and apply the information contained in the line set-up specification, to promptly and efficiently perform change over operations.
· Exhibits knowledge of mechanical and electrical skills, ability to learn and apply new skills and should have good judgment in daily maintenance activities.
· Utilizes the design and specifications for equipment and instrumentation
· Utilizes assigned troubleshooting and regulatory playbooks in partnership with Facilities
· Execute corrective maintenance actions
· Follows up and corrects any safety related design/equipment issues
· Understands how manufacturing SOPs interact with equipment/automation design and operation
· Provide technical support to manufacturing on SOP changes, Deviations, GMP and Safety Investigations/CAPAs
· Execute work orders assigned by end user groups, as well as ones initiated by Engineering when they apply to daily plant support or troubleshooting
· Ensure all site record docs are accurate and up to date (P&IDs, etc.)
· On call support 24/7; expected to carry smartphone device for on-call 24-hour support on a rotational basis.
· Provide support to all phases of the Change Control process for owned changes
· Support in timely closure of equipment related CAPAs
· Provide and/or ensure generation of all supporting documentation (scope documents; approval slides; work orders; protocols)
· Partners with other engineers to ensure product quality impact is sufficiently assessed and mitigated as appropriate to project scope.
Qualifications:
College Diploma level education is a minimal requirement. 4-year degree in a scientific or technical discipline is preferred.
Mechanically inclined a plus.
0 – 2 years of experience in food/pharma industry
Must have demonstrated extensive knowledge and experience in a processing equipment related discipline and/or business.
Requires experience with GMP SOPs as they relate to dietary supplements manufacturing.
SAP and/or other data systems experience a plus.
Ability to meet project timelines and assign work to direct reports for meeting department timelines.
Physical Demands
· While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms; stoop and kneel; talk and hear. The employee is frequently required to sit and stand.
· Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus.
· Lifting requirement: Up to the maximum safety-recommended 50 pounds
The physical demands are representative of those that must be met by employee to successfully perform the essential functions of this job. Reasonable accommodations may be made upon request to enable individuals with qualified disabilities to perform the essential functions of the job.
Work Environment
Mainly manufacturing facility where exposed to computerized equipment, moving mechanical parts, forklifts, heavy pallets, moderate to loud noise level, and air-borne dust and powders. While working, will be required to wear various personal protective equipment (e.g., clothing, hair net, face mask, gloves, goggles, etc.).
Experience:
· Relevant: 1 year (Preferred)
Reports to: Plant Engineer
Cross trained to handle the following Jobs: Shipping Receiving and Mechanic II
Parsippany, NJ
1304
140 Littleton Road
Suite 110
Parsippany, NJ 07054
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