The Maintenance Engineer is responsible for completing unscheduled maintenance, preventive maintenance, assisting in improvement project and equipment qualification
- Monitor work order status, follow up with maintenance mechanics to close open work orders in timely manner.
- Ensures timely PM and break down work order execution.
- Review and provide recommendations to preventive maintenance program
- Maintain manufacturing and pkg. machines to perform at optimum performance level to meet production targets
- Maintain inventory of parts for minimum equipment breakdown
- Utilities – Maintain HVAC Systems, USP Water, Boilers, Compressed Air, Hot Water and Electricity supply
- Facility – Maintain facilities all the time to acceptable level of FDA, OSHA and environmental agency compliance.
- Maintenance Budget – Support preparation for annual maintenance budget. Forecast major activities and approximate expenses.
- Coordinates major shut downs with manufacturing and project.
- Corporate office environment
- Manufacturing / Production environment
- Warehouse environment
Environmental related to manufacturing/production environments:
- Noise: Sufficient noise, either constant or intermittent, to cause marked distraction or possible injury to sense of hearing.
- Fumes: Smoky or vaporous emissions, usually odorous, thrown off as the result of combustion or chemical reaction.
- Odors: Unpleasant smells.
- Gases: Examples include carbon monoxide and ozone.
- Dust: Airborne particles of any kind, such as textile dust, wood, and silica.
- Hazards: Conditions where there is danger to life, health or bodily injury such as closeness to moving mechanical parts; working on scaffolding and high places; exposure to burns, radiant energy, explosives, toxic chemicals, and electric shock.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- While performing the duties of this job, the employee is regularly required to use hands to handle and feel and talk and hear. The employee is frequently required to stand, walk, sit, stoop, kneel, crouch, crawl, push, and bend.
- Must be capable of bending and lifting, moving and/or carrying up to 50 pounds.
- Ability to navigate office, lab, and/or plant floor working environments, stands, ambulates, and reaches.
- Must have the ability to wear applicable personal protective equipment utilized at the site, including but not limited to respirators, safety glasses/goggles, and safety shoes.
Travel Estimate Up to 5 %
Education and Job Qualifications:
- Bachelor’s Degree in Engineering or Science related field.
- Technical and analytical ability to analyze engineered systems and equipment operation as well as quality and compliance systems that supports production operations as well as research and development.
- Good understanding of cGMPs and good documentation practices.
- Technical knowledge to write, prepare and execute the Change Controls, Investigations, SOPs, protocols, final summary reports and validation documents.
- Demonstrated excellent communication: verbal, written and presentation skills.
- A self-starter with a hands-on approach and a can-do attitude.
- A team building champion driving innovative cross functional synergies.
- Excellent project management and problem solving skill
- The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
- Minimum of five (5) years in Pharmaceutical, preferably Oral Solid Dosage.
Job Type: Full-time
Pay: $1.00 per year
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Relocation assistance
- Vision insurance
- 8 hour shift
- Monday to Friday
Supplemental pay types:
Work Location: One location