Posted:
12/18/2024, 4:00:00 PM
Location(s):
Rochester, Michigan, United States ⋅ Michigan, United States
Experience Level(s):
Senior
Field(s):
Legal & Compliance
Workplace Type:
On-site
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.
The Sr Automation Compliance Engineer will have overall responsibility for managing regulatory aspects of the process automation and control systems used in the manufacture of sterile injectable. This position will provide engineering and technical support related to the operation, maintenance, installation, startup/commissioning, testing, and qualification of systems within a sterile injectable manufacturing facility.
• Facilitate and participate in the investigation teams created to determine root cause of exemption reports, QARs and laboratory investigation reports.
• Serve as a liaison between quality, Operations and regulatory/Compliance to facilitate timely closure of investigations and/or CAPAs.
• Promote safety within the workplace by following site safety procedures and perform proactive safety assessments, foster a safe work culture.
• Support the operation and troubleshooting of manufacturing equipment and control systems.
• Responsible for investigations and CAPAs related to site Automation system and instrumentation.
• Manage technical writing and document review.
• Support all investigations and audits (internal and external) as needed.
• Takes a tactical role on investigations and improvements partnering with operations, quality, supply, EH&S and other functions.
• Responsible for Periodic review of the Automation systems, user account reviews and procedures.
• Follows Good Documentation Practices per compliance requirements (i.e., 21 CFR Part 11, Data Integrity).
• Provides support and guidance to Automation and Maintenance Technicians in Good Documentation Practices.
• Ensure calibrations in compliance with site policies and procedure and assuring traceability to the National Institute of Standards and Technology (N.I.S.T.).
• Develop, review/update Calibration/Automation Job Aids/Procedures.
• Generate, review/approve (as SME) and update required Calibration documentation (i.e., instrument form).
• Provide off-shift and on call support when necessary.
• Generate, review/approve (as SME) and update Automated System Life Cycle documents.
• Responsible for implementation of compliance initiatives (i.e. Automation Change Control, Periodic reviews, Alarm Management, Compliance Metrics).
• Design and implementation support for minor functional and process changes, either smaller.
projects, remediation activities or capital projects.
• Support FAT/commissioning/qualification activities as required.
•Support future capital projects and assure site automation standards are followed.
• Assist other departments in evaluating historical process/equipment data.
• Provide automation guidance and training to other functional groups (i.e. Operations, Validation, Maintenance, etc.).
• Applicant must have HS Diploma with eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.
• Demonstrated experience in Automation Engineering experience with System Development Lifecycle (i.e. user requirements, system design specification, system impact assessment documents)
• Experience on Automation Compliance with strong knowledge of Computerized Systems Validation, Compliance regulations (i.e., 21 CFR Part 11, Data Integrity) and Automation standards (GAMP).
• Experience with Root Cause Failure Analysis, Equipment Criticality Ranking, PM/PdM optimization, and/or Failure Modes and Effects Analysis
• Understanding and experience with process automation systems and calibration.
• Strong knowledge and understanding of Current Good Manufacturing Practices {part of GxP}
• Excellent oral and written communication skills
• Excellent interpersonal effectiveness and communication skills (written and oral).
• Working knowledge of MS application (i.e. Excel, Word, Outlook, Teams, Power Point, Visio, Project, etc.)
Understanding of computer programming languages, cyber security, Network+.
PHYSICAL/MENTAL REQUIREMENTS
• This is an on-site role at a penicillin manufacturing facility. Candidates must not be allergic
to penicillin.
• Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and
complex data analysis, problem solving.
• Ability to write general correspondence and technical reports.
• Requires good written, oral communication and presentation skills.
• Requires good planning, organizing, time management and team participation skills.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Regular Work Schedule:
Standard (M-F) daytime. Overtime work may be required. Work requires on-site presence.
Occasional national/international travel for equipment factory acceptance testing, training
seminars, vendor meetings, work progress meetings, etc.
Non-Regular Work Schedule:
At different times of the year, this position will work long hours for scheduled manufacturing
shutdown periods and throughout the year may be required to work late with little notice as
need arises when equipment is unexpectedly down.
•Demonstrate proficiency in cGMP, GAMP, software development life cycle, environmental,
health and safety procedures to assure compliance with regulatory, policies and/or
established guidelines.
•Observe and notify any risk situation for the environment, health or safety. Assure that all
automation engineering initiatives comply with all regulatory agency requirements.
Relocation support available
Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Website: https://www.pfizer.com/
Headquarter Location: New York, New York, United States
Employee Count: 10001+
Year Founded: 1849
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine