Pfizer Engineering & Maintenance Compliance Leader in United States
Working with project engineering, maintenance, and utilities, coordinates compliance components on this department, for all equipment/system, including but not limited to change controls, deviations, investigations, supporting documentation like SOPs, IQ/OQ/PQ protocols and reports, etc. This role is the natural connection between the Engineering & Maintenance departments with the key compliance areas such as Quality Systems, Validation, Quality Assurance, Documentation, EHS, etc.
Responsible for Maintenance & Engineering related Change Controls, SOP's, Protocols, training, etc. and coordinates the documentation activities ensuring the completion of tasks/documentation milestones.
Supports maintenance and engineering related investigations, CAPAs, action plans, working closely with maintenance and reliability leaders.
Responsible for equipment commissioning, decommissioning, validation, and all related activities that require a compliance point of view.
Supports the review of validation processes and protocols and procedures currently in place by providing improvement ideas, updating documents following cGMPs and Pfizer's Quality Standards.
Assists in the review of IQ/OQ/PQ deviations, provides troubleshooting expertise, and develops recommendations and corrective actions in collaboration with the maintenance and engineering team.
Responsible for ensuring all applicable equipment and utilities documentation is created, revised, and in-place to guarantee consistency within cGMP and Pfizer Quality Standards.
Prepares and supervises the completion and revision of effective maintenance procedures so that equipment, systems, processes, and facilities, perform as designed and validated.
Represents Maintenance & Engineering department in Site Quality Review Meetings, Change Control Review Committee, Safety Committee and compliance related activities at the site.
Develops, leads, engages and supports the maintenance team and creates an atmosphere of team effort and open communication.
Provides information support during FDA and Quality Assurance audits.
Will se rve as the natural backup for maintenance positions such as Reliability Engineer, TL Maintenance and Planner/scheduler. Which means that this role will learn the use of systems like EAMS, Ariba, etc .
BS in scientific or engineering discipline.
Minimum of three years' experience in pharmaceutical facilities & equipment
Knowledge of GMP, OSHA and FDA regulations applicable to the pharmaceutical industry
Experience in reliability based maintenance practices.
Proven leadership ability, decision making ability, and excellent oral and written communication skills are essential.
Aseptic manufacturing experience.
Quality Assurance, quality systems, validation or related experience may be helpful for this role.
Demonstrated ability to interact effectively with all levels of the organization.
Candidate must possess flexibility to respond to constantly changing conditions and priorities.
This position is in a Penicillin Facility. The candidate must NOT be allergic to Penicillin.
Collects and researches data; gathers and analyzes information skillfully; approaches problems objectively and systematically; draws accurate conclusions from complex information.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
At different times of the year, this position will work long hours for scheduled manufacturing shutdown periods
(Throughout the year) May be required to work late with little notice as need arises when equipment is unexpectedly down.
This position will be on-call screening alarms and dispatching technicians 24/7 on a rotating schedule with other colleagues.
Limited travel may be required.
Contacts within the site
Senior Manager of Engineering and Maintenance
Maintenance Team Leader and Reliability Leader
Team Leaders and colleagues from Penicillin Manufacturing and Packaging Departments
Validation and Quality Assurance
Safety, Security, Union Representatives
Contacts outside the site
Vendors and Technical Representatives of equipment and parts manufacturers
Technicians and engineers from outside contractors
Federal and State Inspectors
Colleagues from another Pfizer sites.
Indicate the Average Budget or Revenue accountability, as applicable.
Although not directly accountable for the budget, this role is obligated to be fiscally responsible for maintenance spending on parts and contracted work.
Indicate the typical number of Colleagues managed; include direct & indirect reports and matrix responsibility. Note if direct reports are people managers or individual contributors. Indicate additional resources (i.e. contingent workers) managed, as applicable.
This position is an individual contributor.
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.
The job is open only to Protected Individuals (as defined by 8 U.S.C. § 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.
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.
Additional Offer Details:
Last Date to Apply for Job: June 8, 2018
Eligible for Relocation Package - Yes
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.