Senior Manufacturing Support Engineer

Sr. Manufacturing Support Engineer

Sr. Manufacturing Support Engineer support engineering & advanced troubleshooting activities for pharmaceutical manufacturing equipment and critical systems, and maintain compliance with all state and federal guidelines with emphasis on current Good Manufacturing Practices (cGMPs) requirements.

Area Of Responsibility

Provides advanced troubleshooting, rapid recovery, on-call response, directly involved with uptime, execute approve changes, and possess deep knowledge as an SME for the following equipment:

Isolators/vial fill line

Lyophilizer and loader isolator

Powder filling machine

Automatic labelling machine

Secondary packaging (i.e Serialization / Aggregation)

Autoclaves

Sterilizers

Washers

Support Manufacturing Engineer with retrofit and upgrade projects, but does not own projects

Troubleshoot process equipment/sterile filling

Ensuring smooth operations of process and filling equipment

Develop and maintain records on pharmaceutical manufacturing equipment and systems to maintain operations and validation

Operate production equipment for setup and or production purposes as needed

Perform non-routine and off-hours tasks as necessary

Support area validation, calibration, certification efforts, and the transfer of new processes to the manufacturing area

Supports updates or improvement on maintenance SOPs for equipment

Follow all company policies related to job safety

Lead troubleshooting for complex problems related to manufacturing and critical systems

Supports Manufacturing Engineer with improvements, upgrades and enhancements of manufacturing & critical systems

Support validation maintenance program

Support in the development and mentor of peers

Monitor process operations to ensure compliance with specification

Ensure equipment operational readiness

Provide Re-Qualification support for process equipment

Provide equipment operational support, including being on call 24/7 (required)

Support change controls, deviations and CAPAs, but does not own quality records

Support Manufacturing Engineer and Validation Engineer with remediation during FAT/SAT/ IQ/OQ/PQ, but does not own the completion of this documents

Performs advance troubleshooting applying knowledge in Mechanical, Electrical, automation and process fields.

Other duties as assigned

Work Conditions:

Office

Lab

Shop/shipping areas

Some exposure to noise, hot and cold, outside elements, radiation exposure within allowable limits

Physical Requirements:

Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, talk, hear, taste, smell

Close, distance and peripheral vision; depth perception, ability to focus

Ability to operate production equipment and hand tools

Operate hand truck

Operate company truck

Current, valid Driver's license

Operate computer/office machines

Wear Safety shoes, safety glasses, gloves

Lift up to 70 lbs.

Ability to work a flexible schedule

Travel Estimate

Up to 5%

Education and Job Qualification

BS. Mechanical Engineer preferred or equivalent

High school diploma or equivalent required

Technical certification preferred

Knowledge of pharmaceutical Plant/Maintenance/manufacturing Operations or related environment

Knowledge of aseptic techniques

Ability to read & create engineering drawings

State boilers Special License to Operate or higher preferred / obtain within 6 months of employment

Electricians license preferred

Ability to plan, prioritize and organize diversified workload

Familiarity with use of computers and MS Office

Experience

Minimum 10+ years related experience or BS in Engineering + 6 years or AS in STEM field + 8 years

Experience working with electronic document systems (CMMS work orders, LMS, Track Wise, Master Control) or similar systems

Experience with Building Automation Systems

HAZMAT training

Formal cGMP training

Proficient with use of hand tools and power equipment

R.O./ D.I. water system experiences a plus

The presently-anticipated base compensation pay range for this position is $79,000 to $87,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.