Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

Serve as a key technical resource for engineering design and maintenance of Purified Water, WFI, Steam, and Air Handling Equipment. Evaluate aged systems, assess current and future utility support infrastructure needs, and recommend solutions. Ensure compliance with cGMP requirements for facilities and utilities. Troubleshoot issues, develop, and execute projects to prevent recurrence within budget. Design concepts, create detailed design documents, specify equipment, perform engineering calculations, manage RFPs, coordinate with stakeholders, and oversee project closure.

Responsibilities

Provide engineering guidance and serve as a subject matter expert on HVAC Systems, Purified Water Systems, Steam, and WFI.
Investigate root causes of failures and recommend short-term and long-term fixes.
Evaluate systems for gaps in robustness and cGMP adherence and develop/execute remediation plans.
Resolve high-level technical processing issues related to equipment operation.
Troubleshoot complex automated equipment and processes.
Support management of complex, multidisciplinary projects, including budget and scope changes.
Provide input to detailed project plans and timelines using project management tools.
Coordinate project timelines with other departments, contractors, and vendors.
Follow through on technical project responsibilities, including identifying phases, assigning personnel, and reviewing bids.
Support new equipment start-up training initiatives and work with maintenance and production to ensure appropriate training.
Determine project specifications by studying product design, customer requirements, and performance standards.
Prepare cost estimates for projects.
Provide design documents including P&ID drawings, process piping sizing, instrumentation, flow calculations, and electrical/mechanical/pneumatic drawings.
Act as a subject matter expert for equipment operation and efficiencies.
Assist with process improvement initiatives for efficient process systems and controls.

Requirements

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.
Strong background in technical troubleshooting and 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.
Ability to think in high-level terms to develop engineering solutions for new processes.
Ability to think in specific, detailed terms when problem-solving for existing processes.
Decisions require complex analytical judgment.
Plan and perform a wide variety of duties requiring general knowledge of company policies and procedures.
Use 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.
Provide project direction to other employees.
Requires contacts to carry out company policy and programs.
Must often deal with people of substantially higher rank on matters requiring explanation, persuasion and obtaining approvals.
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.

Skills

Technical troubleshooting
Problem solving
Equipment operation
Validation requirements
Pharmaceutical cGMP requirements
System specification
Equipment procurement
Installation oversight
Commissioning
Project management
Regulatory requirements for manufacturing pharmaceutical products
P&ID drawings
Process piping sizing
Instrumentation
Flow calculations
Electrical/mechanical/pneumatic drawings
Microsoft Project

Location

Rochester, NY

Work Type

Full-time

Experience Level

Senior

Education Level

MS degree in Engineering
BS degree in Engineering

Salary/Compensations

0.00 - 0.00 USD

Benefits

100% employer-paid medical premiums
401(k) contributions: 6% match plus an additional 4% company-funded contribution
HSA contributions with wellness incentives
Annual performance bonuses
Merit increase eligibility

About the Company

French pharmaceutical industrial group striving to make healthcare solutions accessible.
World leader in sterile single dose with 10 sites on 4 continents and over 2400 employees.
Unither Manufacturing LLC. in Rochester (NY) specializes in Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules, with over 360 employees.
Dynamic company driven by a spirit of victory, pursuing strong growth while maintaining a close relationship with customers and employees.
Culture based on 5 values: Respect, Responsibility, Trust, Courage and Innovation.
Committed to providing employees with autonomy, encouraging initiatives, and offering working conditions conducive to development and potential expression.
Site values the meaning of work and entrusts employees with a high level of responsibility.

Equal Opportunity

Unither is an Equal Opportunity Employer.
Committed to providing reasonable accommodations for qualified individuals with disabilities.
Ensuring equal employment opportunity for all applicants.