At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.
JOB SUMMARY:
Provide daily support for all automated process systems and computer controlled equipment and processes. Provide leadership as the Computer System Owner for process related systems. Oversee process system operations, maintenance, support and validation. Oversee all facility environmental monitoring including LACES as it relates to environmental monitoring, pest control and filter testing lab.
Additional job specific requirements/responsibilities are contained in approved training curricula.
JOB RESPONSIBILITIES:
Oversee operation and maintenance of assigned automated and computer controlled process systems, process equipment. Provide leadership for the environmental monitoring program for the entire facility. Ensure the program meets cGMP and regulatory requirements. Make recommendations to enhance manufacturing processes, utilities and equipment controls supporting manufacturing processes.
Oversee daily activities associated with filter testing and documentation.
Provide Validation and QA support on system design, operation, processes and validation. Support testing of new control systems. Work closely with Process and Project Engineers and maintenance to support the facility. Provide continuous evaluation of all automated process control systems.
Assist in the investigation of manufacturing discrepancies for building related excursions. Review and approve resulting MIRs ensuring accuracy and timely completion.
Follow up on corrective actions, commitments and audit findings in a timely manner. Review design specifications to meet regulatory compliance and address all observations.
Audit batch records, charts, printouts, log books and system logs for accuracy, completeness, GMP compliance and optimal operating conditions. Ensure that errors are reviewed and corrected.
Initiate system updates, upgrades and change control submissions pertaining to automated and computer controlled process equipment and systems. Ensure change control submissions are completed in an efficient and timely manner.
Ensure all equipment and computer controlled process SOPs are current revision and reflect accurate system operation. Provide technical guidance, training and assistance for hardware and software applications. Write control system user requirements and design specifications. Oversee daily process functions and provide direction to staff. Support production activities and manage the activities of on-site contractors.
BASIC QUALIFICATIONS:
BS in Biological Science or Engineering.
Knowledge of cGMPs, process and automated equipment, documentation, compliance and regulatory.
Good verbal and written communication skills
Knowledge of PLC ladder logic
Experience with Allen-Bradley and other PLC systems
BS + 10 years
MS + 8 years
PhD + 2 years
Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs.
For more information and to apply online, please visit us at: www.wyeth.com/careers
Wyeth is an Equal Opportunity Employer, M/F/D/V.
Search Firm Representatives:
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Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into prior with Wyeth to January 2004 is hereinafter vo
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