Facilities Engineer-Senior

Who we are?

As a French pharmaceutical industrial group, we strive to make healthcare solutions that improve and simplify patients' lives accessible to as many people as possible.

As a world leader in sterile single dose, we have 10 sites on 4 continents and more than 2400 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 360 employees.

Your role

Reporting to the Lead Facilities Engineer,

JOB SUMMARY:

Work as a key technical resource in supporting company objectives withrespect to engineering design and maintenance of Purified Water, WFI, Steam andAir Handling Equipment. Evaluate aged systems and make cost/benefit recommendations on whereto invest capital based on future growth outlook. Evaluate current utilitysupport infrastructure and future need and recommend solutions to support bothwith labor, training and automation. Familiar with regulated environments,specifically cGMP requirements relating to facilities and utilities. Responsibilities include working with and/or leadingthe team to help troubleshoot issues then identify, develop and executeprojects to reduce the likelihood of recurrence within budget. Able to design concepts with the users;providing detailed design documents for some projects (e.g. P&IDs,construction drawings); equipment and instrument specification andinstallation; engineering calculations, developing request for proposals to bidprojects; coordination with customers, contractors and consultants; reviewingdocuments, preparing capital appropriation requests, creating purchase orders,reviewing and paying invoices; monitoring progress; assisting with training;executing commissioning activities; and ensuring proper project closure.

ESSENTIAL FUNCTIONS / RESPONSIBILITIES:
Engineering Guidance & Advice (40%)
Subject Matter Expert on HVAC Systems, Purified Water Systems, Steam and WFI for all internal requirements as well as explanation to regulatory bodies during audits and inspections.
Able to provide investigation into root cause of failures, recommend short-term and long-term fixes.
Evaluate systems for gaps in robustness and cGMP adherence and develop and execute plans to remediate.
Resolves high-level technical processing issues related to equipment operation.
Position is, at times, hands-on requiring trouble shooting of complex automated equipment and processes.

Capital Improvements Meet Requirements for Intended Use (40%)
Support management of complex, multidisciplinary projects including project spending and project scope changes to ensure that required deliverables are realized within approved spending limits.
Provide input to detailed project plans and timelines using project management tools such as Microsoft Project, and coordinates and ensures timelines with other departments (QA/Validation, Engineering, Operations, outside Contractors and Vendors, etc.)
Follow through on technical project responsibilities by identifying project phases and elements; assigning personnel to phases and elements; reviewing bids from contractors for technical accuracy.
Supports new equipment start up training initiatives as required. Works closely with maintenance and production to assure appropriate resources are trained on process and control systems.

Technical Solutions (20%)
Determines project specifications by studying product design, customer requirements, and performance standards; completing technical studies; preparing cost estimates.
Provides design documents for appropriate capital or improvement projects including P&ID drawings, process piping sizing, instrumentation, flow calculations, electrical/mechanical/pneumatic drawings, etc.
Acts as a subject matter expert for equipment operation and equipment efficiencies.
Assists with process improvement initiatives associated with delivering efficient process systems and controls.

Your profile

• EDUCATION & EXPERIENCE:
  MS degree in an Engineering discipline preferred with a minimum 8 years in a manufacturing environment with responsibility for facilities, utilities or HVAC systems.
  BS degree in an Engineering discipline required with a minimum 5 years in a manufacturing environment with responsibility for facilities, utilities or HVAC systems.
  Minimum 5 years regulated industry experience, Pharma experience preferred.
  Experience with purified water systems is highly desired.
  Experience in sterile manufacturing is a benefit but is not required.
  
  KNOWLEDGESKILLS & ABILITIES:
  Strong background in technical troubleshooting, problem solving.
  Detailed knowledge of equipment operation and validation requirements.
  Proficient knowledge of pharmaceutical cGMP requirements and systems.
  Ability to specify, procure, oversee installation, and commission systems and processing equipment.
  Strong project management skills.
  Knowledge of regulatory requirements for manufacturing pharmaceutical products.
  This position requires the ability to think in high level terms to develop engineering solutions for new processes. It also requires the ability to think in specific, detailed terms when problem solving for existing processes.
  
  SCOPE OF DECISION-MAKING: Decisions require complex analyticaljudgment. Plan and perform a widevariety of duties requiring general knowledge of company policies andprocedures applicable within area of responsibilities, and including theirapplication to cases not routinely covered. Generals' considerable judgment to work independently toward generalresults, devise methods, modify or adapt standard procedures to meet differentconditions, make decisions based on precedent and company policies.
  
  LEVEL OF SUPERVISION PROVIDED: Project direction of other employeesperforming the same or directly related work, including assigning, reviewing,checking work, eliminating ordinary supervisory/management positions.
  
  INTERNAL / EXTERNAL CONTACTS: Regular inside and outside: Requirescontacts to carry out company policy and programs. Improper handling will have considerableeffect on operating results. Must often deal with people of substantiallyhigher rank on matters requiring explanation, persuasion and obtainingapprovals.
  
  PHYSICALREQUIREMENTS/ENVIRONMENT:
  Standing/walking 90% of time, sitting 10 % of time.
  Work in tight or enclosed spaces, heights, and near moving mechanical parts.
  Moderate lifting with up to 100 lbs. required at times.
  Frequent reaching, pulling, bending, climbing, kneeling, bending, especially in areas requiring repair or installation.
  Exposure to loud noises, and hot/cold temperatures.
  Must wear personal protective equipment and any gowning required by cGMPs.

Compensation range

0,00 - 0,00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

A Smarter Total Compensation Package

At Unither, your base salary is just the beginning. Our Total Rewards include:

• 100% employer-paid medical premiums (a $2,000-$6,000+ annual value)
• 401(k) contributions: 6% match plus an additional 4% company-funded contribution
• HSA contributions with wellness incentives
• Annual performance bonuses and merit increase eligibility
• And more-because we invest in your health, your future, and your peace of mind.

It's a package designed to reward impact-not just hours worked.

More Than Just a PaycheckAt Unither, we don't just offer competitive hourly wages-we also pay 100% of your medical premiums. That means no paycheck deductions for your healthcare, which can be worth an extra $1 to $3.50 an hour in your pocket compared to jobs where you pay part of the premium.

Learn more about us:

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

Join us and make a difference!

Unither is an Equal Opportunity Employer. We are committed to providing reasonable accommodations for qualified individuals with disabilities and to ensuring equal employment opportunity for all applicants.