Senior LDM Process Engineer
Job Description
Why Patients Need You
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 will help bring medicines to the world even faster by imagining what’s possible and taking action.
What You Will Achieve
ROLE SUMMARY
The Andover Liquid Dose Manufacturing (AN-LDM) Senior Process Engineer within the Pharmaceutical Research and Development (PhRD) organization supports the Clinical Manufacturing (CM) Group. The position will report to the Director of PhRD Clinical Manufacturing Technology in Andover MA.
The applicant will provide process/production engineering subject matter expertise (SME) across a variety of unit operations, possess a process design and validation background and production related troubleshooting skills, and demonstrate project management skills for small to medium size projects to support the full lifecycle of pharmaceutical assets.
The applicant will provide engineering technical support related to the maintenance, installation, startup/commissioning, testing, and qualification of process equipment, process related systems, and infrastructure equipment within a variety of PhRD facilities.
The applicant shall provide detailed engineering on change controls and functionality upgrades to existing systems.
The applicant will interact with key stakeholders across all areas of the facilities, interpreting the asset requirements to bring them together with the aim of ensuring high asset performance as defined by the following:
- Establish & Support a Cleaning program for certain assets within LDM collaborating with Validation, Operations, and Quality functions
- EAMS (CMMS) for all PM/CM activities by trended analysis
- Collaboration with Quality Unit for all change management and compliance related activities to meet minimum Quality System requirements
- PM support and maintenance support
- Interaction with Service Contractors & LDM Asset Lead for key critical assets for LDM
- Operator Care understanding
How You Will Achieve It
Role Responsibilities
The Process Engineer will reside primarily on-site focused on the following key responsibilities:
- Lead the execution of troubleshooting activities for multiple unit operations within the Clinical Manufacturing and PhRD facilities in direct support of offline and real time GMP production operations
- Execute commissioning plans, validation/qualification documents, troubleshooting, executing the qualification activities, assisting maintenance, attending necessary meetings, and maintaining specific training requirements
- Design and implementation of ALCOA (Attributable to the person generating the data, Legible and permanent, Contemporaneous, Original record (or true copy) and Accurate) ensuring principles of data integrity are met in all process system designs Collaborate to innovate and develop ideas with all relevant organizations that support the manufacture of Drug Product including but not limited to Quality, Validation, Operations, and Compliance.
- Job requirements require the ability to achieve and maintain access to Grade A area facility gowning and aseptic methods
- Job requirements may involve fill finish, lyophilization and labeling/inspection process equipment; and cell culture, harvest, & purification process equipment, development of user requirement specification (URS), functional requirement specification (FRS) and maintenance recommendations and procedures
- Skilled at the use of Enterprise systems like QTS (Quality Tracking System), EAMS (Enterprise Asset Management System)
- Develops and manages plans to achieve objective; to include mentoring/coaching of junior engineers
- The position will require equipment maintenance history review, investigation, and audit support
- Supporting in-suite process activities for AN-LDM production in a clean room environment, ISO class 5 (Grade A)
- Design asset changes & Maintenance of all LDM assets in EAMS
- Collaborates with engineers and user-base for all asset upgrades
- Ensures the assets remains on schedule & compliant
- Contribute to weekly POR (Plan of record) sustainable asset performance for All Drug Product Fills
- Contribute to ongoing reporting of the asset status
- In addition to Drug Product assets the job requirements may involve support of process related equipment for cell culture, harvest, or purification related assets
Problem Solving/Decision Making:
- Work is achieved by individual or through project teams, utilizing technical or subject matter expertise to achieve results. Requires relevant scientific education, skills, and knowledge
- Troubleshooting problems as they arise on an asset – finding efficient and effective solutions with engineering
- Ensuring that ALCOA (Attributable to the person generating the data, Legible and permanent, Contemporaneous, Original record (or true copy) and Accurate) principles of data integrity are met in all asset activities
- Requires exceptional knowledge of own discipline and advanced knowledge of others and applies these skills to ensure a Sub Business Unit/Sub Operating Unit meets its goals
- Applying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs
- Makes decisions that may require developing new options to resolve complex problems
- Makes decisions guided by policies in non-standard situations
Leadership:
- Creates an environment where innovation is standard taking appropriate risks to advance innovative processes
- Develops ideas and leads complex projects across Sub Business Unit/Sub Operating Unit
- Develops innovative solutions to complex problems impacting a Sub Business Unit/Sub Operating Unit
- Exercises own judgment and is a resource for others. Works independently with assignments often self-initiated Collaborate to innovate and develop ideas with all relevant organizations that support the manufacture of Drug Product including but not limited to Quality, Validation, Operations, and Compliance.
- Ensures the assets remains on schedule & compliant
- Contribute to weekly POR (Plan of record) sustainable asset performance for All Drug Product Fills
- Contribute to ongoing reporting of the asset status
- In addition to Drug Product assets the job requirements may involve support of process related equipment for cell culture, harvest, or purification related assets
Qualifications
Must-Have
- Candidate must have a BS or MS in chemical, mechanical engineering, or relevant discipline
- Candidates must have a minimum of 9 years (7 years with MS) of experience in Process/Production engineering with pharmaceutical process systems executing design, commissioning, and troubleshooting activities
OR
- Candidates with same or more experience in Innovative or Technology Industry with relevant preferred qualifications
- Candidate is required to have experience with Data Integrity and 21CFR Part 11 (GMP for finished Pharmaceuticals)
- Expertise to include systems and equipment within one or more of the following areas: biologics drug substance, biologics drug product and GMP utilities
Preferred Qualifications
- Relevant Computer skills
- Aseptic cGMP Drug Product Manufacturing experience
- Ability to work across functional areas such as operations, maintenance, and validation are required to provide appropriate support
- Ability to work self-directed, and exercise considerable latitude in determining objectives and approaches to assignments and provides guidance and manages work activities of others.
- Good communication skills, verbal and written, are required
- They must have a working knowledge of cGMP type systems and practices
PHYSICAL/MENTAL REQUIREMENTS
- Collaborative skills and effective partnering skills in complex working environments.
- Ability to work in a dynamic multi-discipline organizational model.
- Ability to focus in an open concept work environment
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Minimal travel required.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $117,300.00 to $195,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
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.
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.
