Sr. Process Engineer - Operations Professional (Compliance)
The Sr. Process Engineer/Operations Professional (Compliance) is a role within McPherson Operations supporting technical business needs related to all aspects of manufacturing. This role is the Operations lead overseeing and driving performance, consistency and compliance within Investigations, CAPA, Change Control and Operations metrics. The role will lead continuous improvement activities including cost improvement initiatives and Operational reliability. This role partners with the business units on new product/processes including development, implementation, and life-cycle management phases. This role will also partner with Quality Investigations on issue resolution including root-cause analysis and CAPA development, ownership and execution.
Sr. Process Engineer/Operations Professional (Compliance) role to include:
Actively identify and implement improvements in manufacturing procedures or processes. Apply operational excellence tools (M1, M2, Green Belt) supporting continuous improvement to deliver measurable gains/efficiencies.
Ensure Operations team performance, consistency and compliance to prescribed cycle times for investigations, CAPA, and change control including management of Operational metrics
Represent Operations on project teams which include: development, cost improvement, reliability, and other operation key projects.
Provide technical expertise to lead and participate in cross-functional teams to deliver objectives on time.
Direct and support feasibility line trials, engineering runs, batch documentation generation/updates, validation studies, regulatory submission data, and commercial launch planning.
Liaison between project team and Operational functional leaders.
Assist the department managers with metrics, strategic initiatives and projects.
Supports manufacturing in executing and trouble-shooting investigations and owning CAPA to prevent recurrence.
BS in Engineering or BS in a related technical discipline.
4+ years of pharmaceutical experience in Operations, Engineering; 6+ years in other Manufacturing/Operations or Engineering.
Works independently with minimal guidance.
Must be able to work in a team environment.
Demonstrated proficiency in influencing and motivating teams without a direct authority, presenting data, and stakeholder management.
Proven effective verbal and written communication skills.
Demonstrated proficiency in MS Office programs, including MS Project or equivalent.
Green Belt Certification, M1/M2 Certification
Knowledge of cGMPs and manufacturing procedures and standards.
- No unique physical requirements
- Remains organized & positive in ambiguous and fast-paced, rapidly changing situations
- Interface and communicate effectively with multiple stakeholder groups
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Limited travel required. Non-standard work hour support of global conference calls, 24/7 manufacturing, etc. required when needed, though not typical of weekly requirements.
OTHER JOB DETAILS
- Last Date to Apply for Job: August 05, 2021.
- Eligible for Relocation Assistance: No
- Eligible for Employee Referral Bonus: Yes