Job#: 2071649
Job Description:
Job Responsibilities
Essential
? Perform automation control (PLC/HMI) engineering services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement. Automation lead for equipment/software FAT, field testing and commissioning
? Produce and review design drawings and specification documents (URS, FS, DS, etc.).
? Generate, execute, and review design testing, generate and participate in functional specification testing, and perform field inspection services.
? Generate, execute, and review Installation and Operational Qualification protocols.
? Generate, review, and approve GMP Lifecycle Documents (e.g. risk documents, trace matrices, periodic review, etc.) in electronic document management systems.
? Initiate, execute, and track progress of change records.
? Manage personal project activities (design and qualification) following the organizations business processes to deliver results that are right first time, on-time with schedule requirements and reconciled to the budget
? Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
? Support plant operations to assess discrepant events and changes for automation impact
? Deliver automation solutions to resolve operational issues, assist in troubleshooting and providing real time on floor support of manufacturing operations, participate in site coordination meetings and attend network meetings.
? Adhere to site SOPs and WIs for daily and project deliverables and drive improvements to business processes.
? Attendance and participation in department and staff meetings
? Maintain training qualifications.
? Interact with vendors ensure systems meet site requirements
? Manage contractor staff, track project deliverables, and provide status updates to the project team.
? Fosters a positive safety culture in which no one gets hurt.
? Provide diagnostic troubleshooting assistance as required, including off-hour support.
Education and Experience
? Minimum of 8 years applicable automation and/or instrument and control system experience.
? Pharmaceutical/biotech industry/GMP experience is a plus.
Knowledge, Skills and Abilities
? Proficient knowledge of Siemens Building Automation controllers and systems managing interfaces to external systems including OPC Servers, and associated programming languages
? A demonstrated ability to apply automation solutions and troubleshoot complex problems on highly automated equipment to address business needs
? Demonstrate good organizational and time utilization skills.
? Experience with Biopharmaceutical manufacturing, design or/and construction.
? Knowledge of process, utility and building control systems.
? Knowledge of GMP guidelines, experience in generation of controlled documents.
? Qualification experience related to control and computer systems.
? Knowledge of ISA standards, PIDs and practices for instrumentation.
? Knowledge of PID control theories and techniques.
? Ability to create and interpret electrical schematics and PID drawings
? Demonstrate good interpersonal skills with an ability to interact well with a variety of Personalities, discipline skills and educational levels.
? Demonstrate good written and verbal communication skills.
? Ability to comply with cGMP requirements (gowning, documentation, and procedures) for performing work within the manufacturing facility.
? Demonstrate strong working knowledge of PC based programs and web based systems.
? Ability to work independently with no direct supervision.
Work Environment/Physical Demands/Safety Considerations
? Work in a standard office environment.
? May work in the clean room environment that requires gowning in the form of hospital scrubs, coveralls, gloves and steel toe boots. No make-up or jewelry can be worn when working in the clean room environment.
? May work with hazardous materials and chemicals.
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Apex team member can provide.