This position is a 12-hour shift working 5:30 am to 6:00 pm or 5:30 pm to 6:00 am. Week 1 is 48 hours (1.5x pay for hours > 40), Week 2 is 36 hours.
JOB SUMMARY
The Maintenance Mechanic II performs preventative and corrective maintenance on manufacturing process related equipment such as agitators/mixers, dryers, centrifuges, reactors, chillers, cooling towers, air handler units, exhaust fans, autoclaves, blowers, valves, control panels, and various sanitary design pumps and valves within a cleanroom environment. The Maintenance Mechanic II troubleshoots, with minimal supervision, complex utility systems which may include Heating Ventilation and Air Conditioning (HVAC), steam boiler, electronic control systems, refrigeration, electrical, compressed air and gases, Reverse Osmosis (RO) water, waste water treatment, pure/clean steam, and/or other HPI/pharmaceuticals utilities.
The Maintenance Mechanic II also interprets drawings, layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. The Maintenance Mechanic II is involved in new equipment and plant systems installs as necessary.
This position will operate independently while performing routine maintenance and receive minimal instructions on new assignments.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Operate in accordance and compliance with:
o Current cGMP regulations and ICH Q7 guidelines
o Work Rules, Quality Policies (QP), and Standard Operating Procedures (SOP)
o Cardinal Rules of Quality, Delivery and Safety
· Perform all of the duties and responsibilities of a Maintenance Mechanic I as needed in addition to those of a Maintenance Mechanic II
· Perform monthly, quarterly, semi-annual, and annual Preventive Maintenance on both critical and non-critical mechanical, plumbing and electrical equipment
· Perform on-demand maintenance, and advanced repairs on both critical and non-critical mechanical, plumbing and electrical equipment
· Perform equipment and building rounds readings, and is responsible for identifying, mitigating, and reporting building system equipment malfunctions
· Train Maintenance Mechanics (General and I) to successfully perform their jobs
· Author accurate documentation for the operation and maintenance of various utility systems
· Read and understand construction and machine blue prints, including machine drawings, building construction floor plans, P&ID diagrams, electrical drawings, schematics for pneumatic, gas supply, vacuum and high pressure piping systems.
· Responsible for understanding the proper use of engineering and maintenance documentation, which is required under cGMPs. Examples include the Maintenance Work Order System, the Critical Change Request System, SOP documentation, Validation documentation, etc.
· Open and provide details against work orders using CMMS
· Other duties as assigned
QUALIFICATIONS
· High school diploma or equivalent
· A minimum of 3 years of experience in a food, beverage, or pharmaceutical processing environment required
· Must possess general knowledge of the following skill sets: PLC, Electrical, Plumbing, HVAC, Welding, Pneumatic, Gas Supply, Vacuum, Writing/Revising SOPs, PM, cGMP
· Strong communication and interpersonal skills
· Must be customer service oriented
· Ability to evaluate objectively, fairly, and consistently
· Ability to use common hand and shop tools
· Ability to understand and follow directions as given
· Use miscellaneous office equipment (e.g. calculators, computers, FAX machines, copiers, etc.)
OTHER REQUIREMENTS
· Ability to meet or exceed the company’s attendance and punctuality standards
· Ability to read, write, speak and understand English fluently
· Must be able to wear personal protective equipment
· Must be able to respond to visual and audible alarms
· Must have good knowledge of electricity, carpentry and plumbing among other technical skills.
· May work extended hours, weekends as needed, when problems occur or when deadlines must be met
· Excellent ability to communicate problems to both co-workers and management for proper understanding
· Have the ability to evaluate computer related work orders in accordance with accuracy
· Establish and maintain cooperative and effective working relationships with others
PHYSICAL REQUIRMENTS
· Must have good hearing and sight – adequate for safety programs in a pharmaceutical manufacturing plant
· Must be able to sit and/or stand for extended periods
· Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening
· Must be able to lift 35 lbs. or occasionally lift up to 50 lbs
· Ability to wear proper safety equipment when working in the maintenance shopo or plant
· Physical ability to regularly work around and on industrial equipment, including frequent climbing of stairs and ladders, walking, climbing, bending, kneeling, lift, carry push or pull weights up to 75lbs, crouch or squat, twist, stooping and standing.
To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position. Pfanstiehl may assign reasonably related additional duties to individual employees, consistent with company policy.
ABOUT PFANSTIEHL
Pfanstiehl, founded in 1919, is a leader in Carbohydrates and has over 40 years of experience in custom synthesis and process development with a specialty in carbohydrates, nucleosides and high potency APIs. Pfanstiehl’s customers include most of the world’s leading biopharmaceutical and pharmaceutical companies and its products are utilized in market leading drugs that treat life threatening and debilitating diseases including cancer, rheumatoid arthritis, STDs, and diabetes. Increasing regulatory and quality requirement are benefiting biopharmaceutical and pharmaceutical suppliers like Pfanstiehl with high purity, strong cGMP controls and a strong reputation with FDA and other regulatory agencies. Pfanstiehl is the premier manufacturer of cGMP high purity and low endotoxin injectable carbohydrate excipients (“High Purity Ingredients” or “HPIs”) utilized in the formulation and manufacturing of biopharmaceutical drugs and therapies. In addition, the Company specializes in the isolation, purification, custom synthesis and scale-up development of small molecule Active Pharmaceutical Ingredients (API) and High Potency Active Pharmaceutical Ingredients (HPAPI) in gram to multi-ton commercial quantities.
Pfanstiehl has embarked on a long-term growth and investment plan to build a HPI/HPAPI leader.
Job Type: Full-time
Pay: From $32.86 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Referral program
- Vision insurance
Experience level:
Schedule:
- 12 hour shift
- Day shift
- Holidays
- Night shift
- On call
- Overtime
- Weekends as needed
Work setting:
Application Question(s):
- Are you fully vaccinated against COVID-19 or willing to get fully vaccinated?
- Are you legally authorized to work in the United States for Pfanstiehl?
Education:
- High school or equivalent (Required)
Experience:
- Manufacturing Mechanic: 3 years (Required)
- Food, beverage or pharmaceutical: 3 years (Required)
Language:
Work Location: In person