Entry Level Pharmaceutical Validation Jobs in Rochester, NY

Mechanical/Electrical Engineer
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 Mechanical/Electrical Engineer,
JOB SUMMARY:
Serves as a technical resource supportingcompany objectives with respect to engineering design, process, andimplementation with primary focus on machinery used in the packaging productionprocess. Projects include but are notlimited to: manufacturing systems, non-sterile filing systems, packagingsystems, process pumps and piping, utility systems, new facility constructionand upgrades, Serialization and other packaging control systems and applications.
ESSENTIAL DUTIES / RESPONSIBILITIES:
Engagein technical discussions with potential suppliers
Organize and write specifications based on the needs and requirements (URS)
Launch calls for tenders (Request for Proposal, Request for Service)
Ensure the solution designed respects the established specifications(s)
Ensure that technical choices which may deviate from established specifications, or the implicit expectations of internal customers are documented and validated in a formal manner.
ExecuteProjects and Tasks to the approved completion deadlines and within the definedbudget
Work in partnership with external companies
Propose and apply solutions to mitigate and compensate for possible work delays
Proactively alert site management to potential problems
Ensure the successful commissioning of the project
Monitorthe installations and commissioning of equipment
Coordinate the various suppliers and vendors and ensure their compliance to health and safety instructions
Possess adequate technical expertise allowing problem resolution
Respect the data in the specifications
Communicate with Production to coordinate activities with respect to production constraints
Assist with commissioning activities and in putting the equipment into production
Carry out an assessment after each commissioning
Writing feasibility and line trials, qualification protocols, execution of the tests, writing and approval of any resulting reports.
Participatein operator training (training)
Work with internal customers to define the training requirement and provide technical content
Organize training in collaboration with suppliers
As an equipment/process SME, create training documents and deliver training
Studythe technical needs associated with new site investments
Participate in different project groups
Collect and analyze needs from internal stakeholders
Define technical solutions and implementations
Respect the technical, regulatory and quality requirements issued by Management and Quality Assurance.
Take into account the necessary parameters (water production, energy, etc.)
Respect flows, workshop ergonomics and safety constraints
Ensurethe documentation of completed projects is updated
Collect technical drawings from vendors for review and ensure they reflect the realized design
Create technical drawings of the factory and update according to approved documentation practices
Your profile
REQUIRED EDUCATION:
Bachelor's degree in Mechanical Engineering, Electrical Engineering, or related discipline with equivalent experience.
Master's Degree considered a plus.
Associate's degree with highly relevant experience will be considered.
QUALIFICATIONS/EXPERIENCE:
SPECIFIC SKILLS:
This positionrequires the ability to think in high level terms to develop engineeringsolutions for new processes. It alsorequires the ability to think in specific, detailed terms when problem solvingfor existing processes.
Demonstrated ability to perform technical troubleshooting, problem solving. Background related to cGMP manufacturing, filling or packaging systems and equipment a plus
Detailed knowledge of equipment operation and validation requirements. Experience with robotics and vision systems a plus.
Ability to work in a matrix organization with cross-functional teams
Ability to specify, procure, oversee installation, and commission systems and processing equipment.
Strong project management skills.
Proficient knowledge of pharmaceutical cGMP requirements and systems a plus.
PHYSICAL REQUIREMENTS / ENVIRONMENT:
Traditional office environment, with frequent visits to other areas of the facility, including production areas, loading docks, and laboratories.
Must be able to work on a computer for extended periods of time.
Must wear safety glasses and other protective items as required.
Sitting 75% of the day; standing or walking 25%.
Ability to travel for business (Domestic and International)
We are an equal opportunity employer and are committed to fostering aworkplace that is inclusive, respectful, and free from unlawful discrimination.Employment decisions are made based on business needs, job requirements, andindividual qualifications, without regard to race, color, religion, creed, sex(including pregnancy, childbirth, and related medical conditions), sexualorientation, gender identity or expression, national origin, age, disability,genetic information, veteran status, or any other status protected byapplicable federal, state, or local law, in accordance with U.S. Department ofLabor (DOL) and Equal Employment Opportunity Commission (EEOC) guidelines.
This job description is a summary of the job duties and requirementsthat represent the general nature and level of work being performed. Thisdescription is not intended to limit or in any way modify the right ofmanagement to assign, direct and control the work of employees. Inaddition to the above, all employees are expected to read, understand, andcomply with company policies and procedures, regulatory expectations, HSErequirements, quality and department standards, etc. Although certainpositions have specific tasks and responsibilities with respect topharmaceutical quality and safety, the safety and quality of all productsmanufactured by Unither Manufacturing LLC and the Health and Safety of allpersons on-site is, in general, the responsibility of every employee.
Compensation range
85 000,00 - 95 000,00 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.