Facilities Engineer-Senior

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 2,400 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.

About the role

Reporting to the Lead Facilities Engineer, this role serves 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. You will evaluate aged systems, make cost/benefit recommendations for capital investments based on future growth, and assess current utility support infrastructure to recommend solutions for labor, training, and automation. Familiarity with regulated environments, specifically cGMP requirements relating to facilities and utilities, is essential.

Responsibilities

• Engineering Guidance & Advice (40%)
  • Serve as Subject Matter Expert on HVAC Systems, Purified Water Systems, Steam, and WFI for internal requirements and regulatory audits.
  • Investigate root causes of failures, recommend short-term and long-term fixes, and evaluate systems for cGMP adherence.
  • Resolve high-level technical processing issues related to equipment operation, including hands-on troubleshooting of complex automated equipment.
• Capital Improvements (40%)
  • Support management of complex, multidisciplinary projects, ensuring deliverables are met within approved budgets and timelines.
  • Provide input to detailed project plans using tools like Microsoft Project and coordinate with QA/Validation, Engineering, Operations, and external contractors.
  • Review contractor bids for technical accuracy, assign personnel to project phases, and support new equipment start-up training.
• Technical Solutions (20%)
  • Determine project specifications by studying product design, customer requirements, and performance standards; prepare cost estimates.
  • Provide design documents for capital or improvement projects, including P&ID drawings, process piping sizing, instrumentation, and flow calculations.
  • Act as a subject matter expert for equipment operation and efficiencies, assisting with process improvement initiatives.

Requirements

• Education & Experience:
  • MS degree in an Engineering discipline preferred, with a minimum of 8 years in a manufacturing environment (facilities, utilities, or HVAC systems).
  • BS degree in an Engineering discipline required, with a minimum of 5 years in a manufacturing environment (facilities, utilities, or HVAC systems).
  • Minimum 5 years of regulated industry experience (pharma preferred).
  • Experience with purified water systems is highly desired; sterile manufacturing experience is a benefit.
• Skills & Abilities:
  • Strong background in technical troubleshooting and problem-solving.
  • Detailed knowledge of equipment operation and validation requirements.
  • Proficiency in pharmaceutical cGMP requirements and systems.
  • Ability to specify, procure, oversee installation, and commission systems and processing equipment.
  • Strong project management skills and knowledge of regulatory requirements for pharmaceutical manufacturing.
  • Ability to think strategically for new processes and analytically for existing ones.

Scope of Decision-Making

Decisions require complex analytical judgment. You will plan and perform a wide variety of duties, applying general knowledge of company policies and procedures to unique cases. Considerable judgment is needed to work independently, devise methods, modify standard procedures, and make decisions based on precedent and company policies.

Supervision

Provide project direction to other employees performing related work, including assigning, reviewing, and checking work. This role may eliminate the need for ordinary supervisory/management positions.

Internal/External Contacts

Regular internal and external contacts are required to carry out company policy and programs. Improper handling may significantly impact operating results. You will often interact with higher-ranking individuals, requiring explanation, persuasion, and approvals.

Physical Requirements

• Standing/walking 90% of the time; sitting 10% of the time.
• Work in tight or enclosed spaces, at heights, and near moving mechanical parts.
• Moderate lifting (up to 100 lbs.) required occasionally.
• Frequent reaching, pulling, bending, climbing, and kneeling, especially in repair or installation areas.
• Exposure to loud noises and hot/cold temperatures.
• Must wear personal protective equipment and comply with cGMP gowning requirements.

Benefits

• Healthcare: 100% employer-paid medical premiums (a $2,000–$6,000+ annual value).
• Retirement: 401(k) with 6% employer match plus an additional 4% company-funded contribution.
• HSA Contributions: With wellness incentives.
• Bonuses: Annual performance bonuses and merit increase eligibility.

Pay

Individual annual salaries/hourly rates will be determined based on market data, education, experience, qualifications, expertise, and internal equity considerations.

About Us

We are a dynamic company driven by a spirit of victory, pursuing strong growth while maintaining close relationships with customers and employees. Our culture is based on five values: Respect, Responsibility, Trust, Courage, and Innovation. We provide working conditions that foster development and the expression of potential, entrusting employees with a high level of responsibility. Join us to make a difference!

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