The incumbent coordinates with Operations all wet train activities for new/changing production processes. This may include managing all tasks assigned to Process Engineers or managing the activities directly.
ESSENTIAL DUTIES, RESPONSIBILITIES AND ACCOUNTABILITIES:
-Manages all projects assigned to the Process Engineering group.
-Oversees all work assigned to Process Engineers and completes performance appraisals.
-Manages the Process Engineering group to support all aspects of the wet-train production campaigns, including:
-Writes Production documentation: PCLs, BLRs, CLRs, Deviation Investigations
-Requests/recommends equipment modifications
-Requests/recommends and manpower allocation from Production Management / Supervision to ensure that new/changing processes are adequately staffed.
-Provides start-up support, technical guidance, and trouble-shooting
-Trains production personnel on BLRs, PCLs, CLRs, and validation protocols.
-Writes Post Campaign Summaries for production campaigns, and makes recommendations for future campaigns.
-Assists in GMP compliance.
-Reviews, requests, and/or recommends equipment upgrades for Wet Train Production Buildings to improve operability, cycle time, yield, and safety.
-Oversees the execution of any validation associated with a campaign.
-Reviews production documents.
-Works with interdepartmental groups (i.e QC, QA, EH&S, DEA, Chemical Development, and Engineering) to ensure production meets set deadlines and regulatory requirements.
-Ensures that personal and departmental moral, ethical, legal, and behavioral conduct is in compliance with the Siegfried Code of Conduct.
-Adheres to all applicable cGMP, DEA, and SHE regulations.
The incumbent directly supervises up to 6 Process Engineers and is responsible for all staffing, training and performance management of the direct reports.
EDUCATION AND EXPERIENCE:
-MS Degree in Chemical Engineering and 10+ years of experience in process engineering in a batch pharmaceutical industry.
-cGMP experience a must.
-Must have excellent verbal and written communication skills.
-Must be able to work efficiently with people of all levels and cultures.
-Must be very conscientious and detail-oriented.
-Must be a team player.
-Must be a self-starter and initiator.
-Must be able to manage projects and prioritize
Job Type: Full-time
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Ability to commute/relocate:
- Pennsville, NJ 08070: Reliably commute or planning to relocate before starting work (Required)
- Process Engineering: 10 years (Required)
Work Location: One location