Sr. Process Engineer
MilliporeSigma

A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

***Sign on bonus of $5,000 available!***

Your Role:

This role is recognized as a strong technical contributor within the Engineering Team supporting the facility, maintenance, engineering, and asset management for GMP API manufacturing. Strong knowledge of GMP is necessary to effectively perform this role. Tasks will support manufacturing activities in GMP labs, pilot plants, and production plants including assessing equipment for process scale-up, equipment procurement and installation through the capital expenditure process, qualification assistance, and process hazard analysis (PHA) and review. Overall knowledge of all operations on site, including purified water, process gases, compressed/breathingair, HVAC, and other supporting equipment and infrastructure.This role may also interface with customer personnel, auditors, and regulatory authorities, as needed, to communicate system design, qualification, and status.

• Diagnoses process equipment, system, or procedural deficiencies and malfunctions
• Partner with maintenance to resolve equipment issues
• Leads and/or assists in procurement projects for new equipment or systems required to support manufacturing, including obtaining the necessary level of input from stakeholders
• Conducts interactive design with cross-functional team members
• Develops operational procedures to meet governing Environmental or Safety regulations at state and federal levels as well as corporation principles or insurance agency guidelines
• Assists in developing detailed specifications and bid documents that require vendors to submit complete and comparable bids
• Assists in the development of an accurate project scope and executes a developed project plan
• Regularly communicates project status to all affected parties
• Review/verify contract engineering process design packages for completeness and accuracy
• Secures warranties, manuals, drawing and other appropriate documentation
• Act as company representative for final acceptance of new process equipment
• Directs and/or assists in new equipment and/or system startup
• Supports development of documentation for equipment commissioning, qualification and validation activities related to GMP manufacturing to ensure design specifications are met
• Oversight/administration of Allen-Bradley Programmable Logic Controllers (PLC) and DeltaV Process Control Systems (PCS)
• Increase use of PLC/PCS control systems to increase process automation for improved process control, operator efficiency, risk reduction, and safety/environmental improvement
• Personally, or in conjunction with CAD designers, complete process and design drawing updates
• Participates in PHAs and reviews Process Hazard Evaluations (PHE/PPHE) of scaled-up processes and/or chemistry
• Leads and/or assists in process improvement initiatives
• Ensure work is prioritized and managed closely to minimize equipment downtime and disruptions to Operations' schedule

Who you are:

Minimum Qualifications:

• Bachelor's Degree Chemical Engineering, Mechanical Engineering or other Engineering discipline
• 2+ years industrial plant engineering experience in a GMP pharmaceutical manufacturing setting

Preferred Qualifications:

• Experience with FDA, EMA, and other regulatory standards and requirements for clean utility and processes
• Strong understanding regulatory requirements such as ICH Q7, 21CFR Part 210 and 211, 21CFR Part 600, and EMA guidelines as they relate to clean utilities and pharmaceutical manufacturing

• Ability to read and interpret P&IDs, equipment manuals, and electrical/mechanical drawings
• Ability to work independently on a variety of shifts as needed to support the business
• Familiarity with engineering software systems such as AutoCad, AllenBradley Logix platform, and Emerson DeltaV
• Ability to train end users on the operation of new or modified systems
• Working knowledge of current best available technologies for chemical processing
• Ability to work with internal personnel, outside subject matter experts, equipment vendors, and installation contractors to complete a project
• Strong organizational skills, excellent verbal and written communication skills, and demonstrated leadership ability

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

As an employee of the Company, you will be required to comply with all of the Company's COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

Job Requisition ID: 246592

Location: Verona

Career Level: D - Professional (4-9 years)

Working time model: full-time

This job has expired.