Sr. Manager, Process Engineering (Capital Projects and Validation)

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Title: Sr. Manager, Process Engineering (Capital Projects and Validation)

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Division/Site Specific Information

Role reports to the Allentown, PA site and reports to the Clinical Trials Division (CTD). CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our outstanding blend of services includes project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage and much more.

Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters.

Discover Impactful Work:

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. The Sr. Manager, Process Engineering is responsible for leading capital projects, critical process recipe developments and overseeing the compliant operation of clinical packaging and related assembly equipment. The incumbent will own capital project management from business case development through turnover to Validation and will also support ongoing production.

This role requires attention to details, the ability to interact with all levels of the organization, the desire to provide hands on coaching and mentoring of staff, the ability to communicate professionally, and the ability to collaborate with cross-functional groups. They will also demonstrate and promote the company vision of the 4 I’s.

A Day in the Life:

• Uphold Good Manufacturing Practices (GMP) and promote the company’s core values: Integrity,

• Intensity, Innovation, and Involvement, while ensuring all activities are conducted safely and efficiently.

• Lead a team of Engineers, providing technical oversight for packaging and assembly equipment, process development, and technical documentation related to CAPEX onboarding.

• Manage engineering projects focused on design, optimization, and continuous improvement to enhance efficiency, reduce costs, and increase throughput.

• Drive cost-saving initiatives through Practical Process Improvement (PPI) and Lean Six Sigma methodologies.

• Oversee day-to-day execution of capital projects, repairs, and critical recipe developments ensuring alignment with business objectives and revenue deliverables.

• Strategically plan and allocate resources to prioritize and meet project goals.

• Champion long-term continuous improvement efforts across departments by identifying opportunities for process efficiency, waste reduction, and automation through innovative technologies.

• Partner with Sales on RFIs and RFPs for new projects.

• Serve as a technical subject matter expert during compliance audits, client visits, and facility tours.

• Provide technical specifications for engineering designs and equipment upgrades, ensuring adherence to corporate and industry standards.

• Implement best practices for process engineering, ensuring alignment with corporate and industry standards.

• Mentor and develop engineering team members through goal setting, coaching, and professional development initiatives.

• Perform additional duties and lead projects as needed to support evolving business needs.

• Apply Good Manufacturing Principles in all areas of responsibility. Demonstrates and promotes the company vision of the 4 I’s: Integrity, Intensity, Innovation and involvement; conducts all activities in a safe and efficient manner.

Keys to Success:

Education

• Bachelor of Science degree required.

• Advanced degree in Engineering or related discipline preferred.

• Six Sigma Certification or experience in Lean Manufacturing or Process Improvement Methodology highly preferred.

Experience

• 5 years of food, medical device, or pharmaceutical packaging experience OR 6 years of industrial engineering or related experience required.

• Minimum of 3 years of Supervisory Experience of managing personnel.

• Experience in Lean Manufacturing, Six Sigma, and PPI.

Knowledge, Skills, Abilities

• Proficient in leading and managing multiple project engineering driven assignments from start to finish with sound project management methodologies.

• Must be results oriented.

• Must have a high attention to detail.

• Must have good communication skills, both written and verbal to communicate with both internal and external clients.

• Ability to train employees.

• Must have strong interpersonal skills.

• Must have strong analytical skills.

• Must be able to multitask and respond to shifting priorities.

• Must be able to author and interpret technical documentation, including Validation documentation.

• Must provide direction to team and external department related functions and activities.

• Must have a baseline level of mechanical aptitude established by testing.

• Must be proficient with computer software (MS Office) and have expertise with spreadsheets.

• Must have prior mechanical and process equipment experience.

• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.

Physical Requirements / Work Environment

• Ability to work in a manufacturing environment, including cleanroom and warehouse areas.

• Must be able to stand, walk, and perform tasks consistent with site safety requirements.

• Ability to wear appropriate personal protective equipment (PPE) as required.

Benefits

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.