Job Description

Find what drives you on a team with a more than 70-year history of discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Our products serve a wide range of markets, so if your interests lie along the spectrum of Life Sciences to Industrial, youll find a rewarding role here. For the exponentially curious, Pall is a place you can thrive and amplify your impact on the world.

Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, were pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

What youll do

• Administrator of the facility engineering and operations technology applications. This includes SCADA system, Access Control and Security, EMS, PCS, BMS, CMMS, LIMS, MES and system interfaces (servers, workstations, and software).
• Subject Matter Expert (SME) in the design, implementation, operation, and validation of facility automation systems
• Key tasks include system operation, maintenance, calibration, upgrades, backups, commissioning and troubleshooting issues in a regulated environment.
• Lead security program, develop SOPs and profiles.
• Make recommendations for new technology, improvements and lead projects to purchase, install, and test the systems
• Produce reports as required to support critical operations.
• Lead the development and execution of qualification/validation (IQ/OQ/PQ) activities for automation and software systems adhering to the GAMP 5 guidelines. Support equipment qualification activities related to controls and automation.
• Manage qualification schedules to ensure instruments remain in compliance with GMP standards and SOPs.

• Work closely with other departments in ensuring operation and maintenance of the infrastructure/equipment is aligned with maintenance and qualification strategies and execution.
• Organize and maintain equipment files to comply with the quality procedure.
• Commission and document new equipment arrivals.
• Document activities as required by company's quality system.

• Investigate and resolve deviations/exceptions from the predefined acceptance criteria.
• Provide technical assistance to internal departments regarding equipment/devise maintenance.

• Develop a training plan to ensure that the relevant competencies are present and able to handle audit and inspection presentations.
• You can expect many and varied types of tasks, with a large contact interface to internal stakeholders and some external partners.
• Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.

• Perform other related duties as assigned to meet departmental and Company objectives.

Who you are

• Bachelors degree in Engineering or related Science; or equivalent combination of bachelors degree and pertinent, experience in pharmaceutical or other highly regulated industry.
• At least 5-7 years system maintenance experience in a regulated manufacturing or laboratory environment
• Ability to analyze pharmaceutical processes to determine critical parameters and critical quality attributes and design testing in the form of protocols to ensure robust and repeatable process.
• Must have in-depth knowledge of equipment set-up and operation.

• Experienced in GMP equipment qualification/validation.
• Good working knowledge of CMMS, BMS, PCS and EMS
• Knowledgeable about equipment design and operations.

• Knowledgeable in SCADA operation and maintenance.
• Project Management education and experience is an asset.
• Strong written and verbal communication skills.
• Ability to read and comprehend written technical procedures, as-built drawings, P&IDs, schematics as well as cGMP and SOPs.

• Ability to read, program, troubleshoot PLC Ladder Logic and HMI software.
• Exceptional analytical and problem-solving skills
• Experience with databases and electronic documentation systems a plus.

When you join us, youll also be joining Danahers global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, youll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If youve ever wondered whats within you, theres no better time to find out.

Danaher