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Manager/TL Environmental Compliance/Micro Services

Pfizer


Location:
Saint Louis, MO
Date:
03/24/2017
Job Code:
1045695-1852
Pfizer
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Job Details

Job Title Manager/TL Environmental Compliance/Micro Services

JobID 1045695-1852

Location: St. Louis, MO

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



*Role Description*

The Environmental Compliance/Micro Services Manager / TL will be primarily based in Sterile Product Manufacturing building (SPM) and the Sterile Product Support (SPS) building and will provide general oversight to the Environmental Control personnel and provide Microbial Services support to the Sterile Product Manufacturing process. The ideal candidate will possess a working knowledge of aseptic processing requirements, good documentation practices (GDP), good manufacturing practices (GMP) and compliance/regulatory requirements relating to aseptic processing. Develops, directs and leads the Environmental Compliance Oversight of aseptic production activities at the Brentwood campus for St. Louis MMT Operations. In support of site wide objectives, coordinates the Environmental Compliance Technicians support activities, review and approval of area documents such as SOPs and validation protocols from a microbiological/environmental compliance standpoint. Provide Environmental compliance oversight to support aseptic production activities programs involving microbial and particulate control in production areas - cleaning and sanitation, disinfectants, training programs, etc. Coordinates micro support of validation related activity and production preparation, operation and environmental compliance overview. Engaged with cross functional teams as needed to support continuous improvement activities. Assure that Aseptic Manufacturing and Quality Assurance procedures and practices are aligned with Pfizer Quality Standards (PQS). Requires decision making ability related to Incident Investigation, Corrective and Preventive Actions with emphasis on aseptic quality, site priorities, results and achievements. Candidate will be responsible to provide leadership and participate in environmental data release, change control review and approval, manufacturing support, record approvals, investigation review, lab testing changes and project support within the quality organization.



*Responsibilities*

This position leads a team of Environmental Compliance supervisors supporting three shifts with a wide range of responsibilities. The incumbent is responsible for the development, mentoring, and performance management of a team of 14 environmental compliance technicians and supervisors.Become the SME and main POC for microbial technical support for the aseptic manufacturing areas.Ensure documentation practices and systems are in place in compliance cGMPs and standard operating procedures. Work with management teams to ensure programs are in place to support and measure technical skill development.Partners with other Pfizer groups to support identified learning initiatives, as needed. Participates in network sterile injectables meetings (i.e. Aseptic Forum) to bring in Best Practices where required.Supports operational excellence and site transformational initiatives.Facilitates M1 investigations when required.Support process to hire, develop, coach, reward and monitor training and communication staff members. Set and implement objectives and development plans for direct staff as well as indirect departmental and on-the-job training.Support regulatory inspections and audits, respond to requests and findings, and track commitments for Aseptic operations.Support communication process improvements throughout the site and enable replication of good practices between Pfizer sites.Support production of site-wide meetings and special events and visits.



*Qualifications*

Minimum of Bachelor of Science degree in Microbiology, Biology, Chemistry or related technical physical science. Master Degree in related discipline preferred.Minimum of 7 years of related experience. Previous experience as a manager of colleagues is required; two or more years of experience in GMP Aseptic or Sterile Manufacturing environment. Knowledgeable of current trends in Aseptic Manufacturing standards and regulatory compliance requirements for Pharmaceutical/Biological manufacturing (FDA, EU) preferred.Ability to read, analyze and interpret common scientific and technical journals, financial reports (as needed), and legal documents; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; respond to regulatory agencies; and respond to complaints from customers. Ability to gather and analyze information skillfully and present in many forms.The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities. The candidate should have experience in at least several of the following: GMP, Regulatory (worldwide), deviation investigation, drug product lot release, aseptic manufacturing processes, product and process validation, laboratory testing and investigations, and batch record review. * Produces quality work with minimal guidance. Must be able to work in a team environment within own team and across interdepartmental teams. * Analytical - Able to understand technical concepts and complex manufacturing processes * Technical Skills - Excellent knowledge of aseptic manufacturing operations for evaluation of batch status; demonstrated knowledge of laboratory testing and data collection for raw materials and products for evaluation of batch status. * Oral Communication - Listens carefully to gather information and able to provide clarification. Able to express complex ideas in a clear, concise manner. Capable of explaining technical issues to non-technical personnel. * Team Work - Contributes to building a positive team spirit. * Written Communication - Writing style adequately describes technical information and the ability to effectively communicate throughout the organization. * Diversity - Shows respect and sensitivity for personal and cultural differences. * Interpersonal - Interfaces with management and non-management employees in manufacturing, packaging, Inspection, engineering, pharmaceutical technology, regulatory affairs, quality assurance and laboratories * Ethics - Works with integrity and ethically. Maintains confidentiality. * Organizational Support - Supports organization's goals and values. Willing to work together to achieve a common goal. * Adaptability - Able to deal with frequent change, delays, and/or unexpected events. * Dependability - Completes tasks on time or notifies appropriate person of impending delays with an alternate course of action. * Innovation - Meets challenges with resourcefulness. * Judgment - Exhibits sound and accurate judgment. * Professionalism - Treats others with respect and consideration regardless of their status or position. * Quality -Looks for, and suggests ways to improve and promote quality. * Safety and Security - Understands and follows all safety and security procedures, industrial and company based; looks for and suggests safety improvements. PHYSICAL/MENTAL REQUIREMENTS Position requires the ability to sit and/or stand for extended periods and to work in a variety of settings including office areas, aseptic manufacturing areas (be able to gown aseptically), warehouse, etc. and some occasional time spent in clean room classification zones. Additionally, the ability to drive between the local St. Louis sites is necessary.Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.Training presentations may be required to be delivered on all three shifts, although the primary shift for this role is 1st Shift.Will require early day coverage for set up production operations requiring Quality coverage.Observe safety policies and procedures. Practices and promotes safe working environment at all times. Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis. Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site. Must have the ability to work effectively under and manage to strict production, time and performance deadlines.Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis. This manager's work will be accomplished while sitting, walking and standing and will require entry into all manufacturing areas. Attendance and participation in various departmental and leadership team meetings will also be required. Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.This position will require travel between the sites multiple locations (approximately 10 miles apart) and occasional travel outside of St. Louis.Makes decisions of moderate complexity, sometimes with incomplete information and under tight deadlines and pressure. Makes sound decisions based upon a mixture of analysis, wisdom, experience, and judgment. Always acts with integrity.Deals with concepts and complexity comfortably - intellectually sharp, capable and agile. Understands when to inform, consult or escalate. Summarizes information succinctly and accurately and provides clear recommendations based on a combination of the information at hand and regulatory/procedural guidance. Must have the ability to work effectively under and manage to strict production, time and performance deadlines. Occasionally, Aseptic Gowning is required.#LI-SA1



*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. This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. 1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees.





*Manager/TL Environmental Compliance/Micro Services*
*St. Louis, Missouri*
*1045695-1852*


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