Technical Project Coordinator Jobs in Rochester, NY

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.

Reporting to the Lead Facilities Engineer,

Work as a key technical resource in supporting company objectives with respect to engineering design and maintenance of Purified Water, WFI, Steam and Air Handling Equipment. Evaluate aged systems and make cost/benefit recommendations on where to invest capital based on future growth outlook. Evaluate current utility support infrastructure and future need and recommend solutions to support both with labor, training and automation. Familiar with regulated environments, specifically cGMP requirements relating to facilities and utilities.

Responsibilities include working with and/or leading the team to help troubleshoot issues then identify, develop and execute projects 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 and installation; engineering calculations, developing request for proposals to bid projects; coordination with customers, contractors and consultants; reviewing documents, preparing capital appropriation requests, creating purchase orders, reviewing and paying invoices; monitoring progress; assisting with training; executing commissioning activities; and ensuring proper project closure.

• 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 troubleshooting of complex automated equipment and processes.

• 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 coordinate and ensure 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.

• 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.

• 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.
• KNOWLEDGE SKILLS & 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 analytical judgment. Plan and perform a wide variety of duties requiring general knowledge of company policies and procedures applicable within area of responsibilities, and including their application to cases not routinely covered. General's considerable judgment to work independently toward general results, devise methods, modify or adapt standard procedures to meet different conditions, make decisions based on precedent and company policies.
• LEVEL OF SUPERVISION PROVIDED: Project direction of other employees performing the same or directly related work, including assigning, reviewing, checking work, eliminating ordinary supervisory/management positions.
• INTERNAL / EXTERNAL CONTACTS: Regular inside and outside: Requires contacts to carry out company policy and programs. Improper handling will have considerable effect on operating results. Must often deal with people of substantially higher rank on matters requiring explanation, persuasion and obtaining approvals.
• PHYSICAL REQUIREMENTS/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.

0.00 - 0.00USD

*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.

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.

Its a package designed to reward impact—not just hours worked.

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.

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.